Prospective, Multicenter, Post-Market 1 Year Clinical Follow-up Study to Evaluate Safety and Performance of the SUTUREFIX ULTRA and SUTUREFIX CURVED Suture Anchors in Shoulder and Hip Arthroscopic Repair
Conditions: Instability, Joint
Sponsor: Smith & Nephew Orthopaedics AG

Suturefix Ultra Suture Anchor 
Suturefix Curved Suture Anchor
Prospective,  Multicenter, Post-Market  1 year Clinical  
Follow-up Study to evaluate safety and performance of 
the SUTUREFIX ULTRA and SUTUREFIX CURVED  
Suture Anchors in shoulder and hip arthroscopic repair 
Number: 17-5010-06 
Version: 1.0, 09/MAY/2018 
Page: Page 1 of 87 
Sponsor Name and 
Address: 
Smith & Nephew Orthopaedics AG 
Oberneuhofstrasse 10d 
6340 Baar 
Switzerland 
Investigational 
SUTUREFIX ULTRA Suture Anchor  
SUTUREFIX CURVED Suture Anchor 
Protocol Author(s): 
Fiona Schlomowitsch; Mehluli Ndlovu 

Suturefix Ultra Suture Anchor 
Suturefix Curved Suture Anchor
Prospective,  Multicenter, Post-Market  1 year Clinical  
Follow-up Study to evaluate safety and performance of 
the SUTUREFIX ULTRA and SUTUREFIX CURVED  
Suture Anchors in shoulder and hip arthroscopic repair 
Number: 17-5010-06 
Version: 1.0, 09/MAY/2018 
Page: Page 2 of 87 
1. 
SIGNATURES
1.1 
PRINCIPAL INVESTIGATOR SIGNATURE PAGE 
This page will be returned to Smith & Nephew Orthopaedics AG and a copy retained at the 
investigational site. 
I have read the attached protocol entitled I have read the attached protocol entitled”, version 1.0, 
dated 09/MAY/2018, and agree to abide by all provisions set forth herein. 
I agree to comply with the Investigator’s Obligations stipulated in Section 21.4 of the protocol,  
I agree to ensure that the confidential information contained in this document will not be used for 
any purpose other than the conduct of the described clinical investigation without the prior 
written consent of Smith & Nephew Orthopaedics AG
Name 
Signature 
Date Signed 
(DD/MMM/YYYY) 

Suturefix Ultra Suture Anchor 
Suturefix Curved Suture Anchor
Prospective,  Multicenter, Post-Market  1 year Clinical  
Follow-up Study to evaluate safety and performance of 
the SUTUREFIX ULTRA and SUTUREFIX CURVED  
Suture Anchors in shoulder and hip arthroscopic repair 
Number: 17-5010-06 
Version: 1.0, 09/MAY/2018 
Page: Page 3 of 87 
1.2 
SPONSOR APPROVAL
Role 
Approver Name 
Approver Signature 
Date Approved 
(DD/MMM/YYYY) 
Head of Global Clinical 
Operations 
Robert Eichelkraut 
Head of Global Clinical 
Strategy 
Beate Hanson 
Head of Global 
Biostatistics 
Alan Rossington 
Head of Global Data 
Sciences 
Alan Rossington 
Andy Weymann for 
Andy Weymann for
10/MAY/2018
10/MAY/2018
11/MAY/2018
11/MAY/2018

Suturefix Ultra Suture Anchor 
Suturefix Curved Suture Anchor
Prospective,  Multicenter, Post-Market  1 year Clinical  
Follow-up Study to evaluate safety and performance of 
the SUTUREFIX ULTRA and SUTUREFIX CURVED  
Suture Anchors in shoulder and hip arthroscopic repair 
Number: 17-5010-06 
Version: 1.0, 09/MAY/2018 
Page: Page 4 of 87 
SYNOPSIS
2.
Title of Study: Prospective, Multicenter, Post-Market 1 year Clinical Follow-up Study to evaluate 
safety and performance of the SUTUREFIX ULTRA and SUTUREFIX CURVED 
Suture Anchors in shoulder and hip arthroscopic repair 
Study Design: 
•
Prospective
•
Approximately 8 sites:
-
4 sites for hip group
-
4 sites for shoulder group
•
Two-arms (hip and shoulder)
Study Type: 
Post-market study 
Study 
Product: 
SUTUREFIX ULTRA and SUTUREFIX CURVED Suture Anchor 
Study 
Purpose: 
Prospective, multicenter, post-market clinical follow-up to support CE Mark 
certification and Notified Body (BSI) for the Shoulder and Hip repair indications. 
Data to confirm safety and performance levels acceptable for the risk benefit 
profile of the devices.  
Primary 
Objective: 
To demonstrate the performance of the SUTUREFIX ULTRA and SUTUREFIX 
CURVED Suture Anchors in hip and shoulder for arthroscopic treatment over a 
time period of 6 months after arthroscopy. 
Secondary 
Objective: 
To assess safety and performance, supporting the use of SUTUREFIX ULTRA 
and SUTUREFIX CURVED Suture Anchors in hip and shoulder arthroscopy 
repair.  
Statistical 
Rationale: 
The study sample was decided based on the feasibility of recruitment, enrolment 
and follow-up considerations. The study is therefore not powered for any 
statistical testing but will be able to estimate a success rate of 86% with a 95% 
confidence interval (CI) [75: 97]. Previous studies suggest that the success rate 
among patients who have undergone any Suture Anchors for arthroscopic 

Suturefix Ultra Suture Anchor 
Suturefix Curved Suture Anchor
Prospective,  Multicenter, Post-Market  1 year Clinical  
Follow-up Study to evaluate safety and performance of 
the SUTUREFIX ULTRA and SUTUREFIX CURVED  
Suture Anchors in shoulder and hip arthroscopic repair 
Number: 17-5010-06 
Version: 1.0, 09/MAY/2018 
Page: Page 5 of 87 
instability repair is 71-97%. 
Sample Size: A total of 80 subjects; 40 subjects for the shoulder group and 40 subjects for the 
hip group, will receive at least one device, SUTUREFIX ULTRA and/or 
SUTUREFIX CURVED Suture Anchor. A sample size of 40 subjects will estimate 
a success rate of 89% with a 95% confidence interval (CI) [78: 100] with 55% 
probability. 
Number of 
Study Sites: 
Approximately 8 sites: 
•
4 sites for study hip group
•
4 sites for study shoulder group
Targeted 
Global 
Regions: 
Europe 

Suturefix Ultra Suture Anchor 
Suturefix Curved Suture Anchor
Prospective,  Multicenter, Post-Market  1 year Clinical  
Follow-up Study to evaluate safety and performance of 
the SUTUREFIX ULTRA and SUTUREFIX CURVED  
Suture Anchors in shoulder and hip arthroscopic repair 
Number: 17-5010-06 
Version: 1.0, 09/MAY/2018 
Page: Page 6 of 87 
Inclusion 
Criteria: 
All subjects 
1. Subject has consented to participate in the study by signing the EC-approved 
informed consent form
2. Subject is > 18 years of age at time of surgery
3. Subject condition meets proposed indication to SUTUREFIX ULTRA and 
SUTUREFIX CURVED Suture Anchor
4. Subject requiring shoulder or hip arthroscopic labral repair surgery from 
physical findings, subject symptoms and radiographic finding
5. Bone quality and quantity must be adequate to allow proper placement of the 
suture anchor
6. Able to follow instructions.
7. Willing and able to make all required study visits.
Hip subjects
8. FAI (Femoroacetabular Impingement)
Shoulder subjects
9. Subject with a history of recurrent dislocation/subluxation of the shoulder Hip 
Exclusion 
Criteria: 
All subjects 
1. Participation in the treatment period of another clinical trial within thirty (30)
days of Visit  1 (pre-operative)
2. Women who are pregnant, nursing, or of child-bearing potential who are not
utilizing highly effective birth control measures
3. Any subject that meets the definition of a Vulnerable Subject per
ISO14155:2011: individual whose willingness to volunteer in a clinical
investigation could be unduly influenced by the expectation, whether justified
or not, of benefits associated with participation or of retaliatory response
from senior members of a hierarchy in case of refusal to participate
4. Subjects with a history of poor compliance with medical treatment
5. Contraindications or hypersensitivity to the use of the SUTUREFIX ULTRA
and/or SUTUREFIX CURVED Suture Anchor, or their components (e.g.
silicone, polyester). Where material sensitivity is suspected, appropriate
tests should be performed and sensitivity ruled out prior to implantation
6. Prior ipsilateral surgeries performed on the joint space
7. Pathological conditions of bone, such as cystic changes or severe
osteopenia, which would compromise secure anchor fixation
8. Pathological conditions in the soft tissues to be attached that would impair

 
Suturefix Ultra Suture Anchor 
Suturefix Curved Suture Anchor 
 
Prospective,  Multicenter, Post-Market  1 year Clinical  
Follow-up Study to evaluate safety and performance of 
the SUTUREFIX ULTRA and SUTUREFIX CURVED  
Suture Anchors in shoulder and hip arthroscopic repair  
Number: 17-5010-06 
Version: 1.0, 09/MAY/2018 
Page: Page 7 of 87 
 
secure fixation by suture 
9. Comminuted bone surface, which would compromise secure anchor fixation 
10. Physical conditions which would eliminate, or tend to eliminate, adequate 
anchor support or impair healing 
11. Epileptic history 
Hip subjects  
12. Dysplasia latera/central less than 20° 
Shoulder subjects 
13. Glenoid and/or humeral bone loss considered excessive by the treating 
orthopaedic surgeon 
14. MDI: Multi-directional instability 
15. Psychosomatic voluntary shoulder subluxation 

 
Suturefix Ultra Suture Anchor 
Suturefix Curved Suture Anchor 
 
Prospective,  Multicenter, Post-Market  1 year Clinical  
Follow-up Study to evaluate safety and performance of 
the SUTUREFIX ULTRA and SUTUREFIX CURVED  
Suture Anchors in shoulder and hip arthroscopic repair  
Number: 17-5010-06 
Version: 1.0, 09/MAY/2018 
Page: Page 8 of 87 
 
Study 
Duration: 
Study duration: 24 months 
Full analysis: after 12 month follow-up  
Enrollment period: 12 months 
Primary 
endpoint: 
• 
Clinical success rate, defined as subjects without signs of failure and/or re-
intervention at 6 months, as assessed by the surgeon 
Secondary 
endpoint(s): 
• 
Clinical success rate, defined as subjects without signs of failure and/or re-
intervention at 12 months, as assessed by the surgeon 
• 
Intra-operative anchor deployment success rate 
• 
Number of anchors pulled out 
• 
Use of additional anchors as a result of intra operative failure 
• 
Device-related re-intervention 
• 
Safety evaluation at all time points 
• 
Post-operative clinical success rate and performance assessed with subject 
reported outcomes as follows: 
All subjects 
• 
Subject pain assessed with a VAS at 6 months* and 12 months* 
• 
Subject satisfaction assessed with a VAS at 6 months* and 12 months* 
• 
EQ-5D Questionnaire at 6 months* and 12 months* 
Hip subjects 
• 
Hip Outcome Score Activities of Daily Living (HOOS-ADL) at 6 months* and 
12 months* 
• 
Modified Harris Hip Score (HHS) at 6 months* and 12 months* 
Shoulder subjects 
• 
ROWE Shoulder Scores at 6 months* and 12 months* 
• 
ASES Shoulder Scores at 6 months* and 12 months* 
• 
Constant-Murley Shoulder Score at 6 months* and 12 months* 
 
* Patient Reported Outcomes (PROs) are optional and used according to the 
surgeon’s preference 
Safety Data 
AEs, SAEs, ADEs, SADE, USADEs 

 
Suturefix Ultra Suture Anchor 
Suturefix Curved Suture Anchor 
 
Prospective,  Multicenter, Post-Market  1 year Clinical  
Follow-up Study to evaluate safety and performance of 
the SUTUREFIX ULTRA and SUTUREFIX CURVED  
Suture Anchors in shoulder and hip arthroscopic repair  
Number: 17-5010-06 
Version: 1.0, 09/MAY/2018 
Page: Page 9 of 87 
 
 
STUDY SCHEMATIC (should be identical to Table 9.1.1-1) 
Schedule of events (*as needed) 
 
Visit 1 
 
Visit 2 
 
Visit 3 
Visit 
Visit 4 
Telephone 
Call or Visit 
Visit 5 
Unscheduled 
Visit 
Pre-
Operative 
Operative 
through 
Discharge 
6 Months 
(± 1 M) 
12 Months 
(± 1 M) 
 
Informed Consent 
√ 
 
 
 
 
Inclusion/Exclusion Criteria 
√ 
 
 
 
 
Demographics/ Medical  History 
√ 
 
 
 
 
Intra-operative failure as assessed 
by the surgeon 
 
√ 
 
 
 
Post-operative through Discharge  
 
√ 
 
 
 
Post-operative Repair failure 
 
 
√ 
√ 
√ 
All subjects 
Pain assessment with VAS 
 
√** 
 
 
√** 
 
√** 
 
√** 
Satisfaction assessment with VAS 
√** 
 
√** 
√** 
√** 
EQ-5D questionnaire 
√** 
 
√** 
√** 
√** 
Hip 
HOOS-ADL score 
 
√** 
 
√** 
√** 
√** 
Mod. Harris Hip score 
√** 
 
√** 
√** 
√** 
Shoulder 
ROWE Score  
√** 
 
√** 
√** 
√** 
ASES score 
√** 
 
√** 
√** 
√** 
Constant-Murley score 
√** 
 
√** 
√** 
√** 
MRI / Imaging 
√ 
 
√* 
√* 
√* 
Adverse Event Assessment 
 
√ 
√ 
End of Study/Exit   
 
 
√ 
* If needed to investigate repair failure 
** Patient Reported Outcomes (PROs) are optional and used according to the surgeon’s preference 

 
Suturefix Ultra Suture Anchor 
Suturefix Curved Suture Anchor 
 
Prospective,  Multicenter, Post-Market  1 year Clinical  
Follow-up Study to evaluate safety and performance of 
the SUTUREFIX ULTRA and SUTUREFIX CURVED  
Suture Anchors in shoulder and hip arthroscopic repair  
Number: 17-5010-06 
Version: 1.0, 09/MAY/2018 
Page: Page 10 of 87 
 
 CONTENTS  
3.
3.1 
TABLE OF CONTENTS 
1. 
Signatures .......................................................................................................................................... 2 
1.1 
Principal Investigator Signature Page ........................................................................................ 2 
1.2 
Sponsor Approval ...................................................................................................................... 3 
2. 
Synopsis ............................................................................................................................................. 4 
3. 
Contents ........................................................................................................................................... 10 
3.1 
Table of Contents ..................................................................................................................... 10 
3.2 
Table of Tables ........................................................................................................................ 12 
3.3 
Table of Figures ....................................................................................................................... 12 
3.4 
List of Abbreviations ................................................................................................................. 13 
4. 
Introduction ...................................................................................................................................... 16 
4.1 
Background .............................................................................................................................. 16 
4.2 
Literature Summary ................................................................................................................. 18 
4.3 
Study Purpose ......................................................................................................................... 20 
4.4 
Safety Considerations .............................................................................................................. 21 
5. 
Objective(s) ...................................................................................................................................... 22 
5.1 
Primary Objective ..................................................................................................................... 22 
5.2 
Secondary Objective(s) ............................................................................................................ 22 
6. 
Investigational Product(s)................................................................................................................. 23 
6.2 
Product Use ............................................................................................................................. 27 
6.3 
Packaging and Labelling .......................................................................................................... 27 
6.4 
IP/ Ancillary Products and Study Supplies Accountability Procedures .................................... 27 
6.5 
Surgical Technique .................................................................................................................. 27 
7. 
Subject Enrollment and Withdrawal ................................................................................................. 28 
7.1 
Subject Population ................................................................................................................... 28 
7.2 
Inclusion Criteria ...................................................................................................................... 28 
7.3 
Exclusion Criteria ..................................................................................................................... 29 
7.4 
Screening ................................................................................................................................. 30 
7.5 
Informed Consent .................................................................................................................... 31 
7.6 
Enrollment ................................................................................................................................ 32 
7.7 
Lost to Follow-Up ..................................................................................................................... 32 

 
Suturefix Ultra Suture Anchor 
Suturefix Curved Suture Anchor 
 
Prospective,  Multicenter, Post-Market  1 year Clinical  
Follow-up Study to evaluate safety and performance of 
the SUTUREFIX ULTRA and SUTUREFIX CURVED  
Suture Anchors in shoulder and hip arthroscopic repair  
Number: 17-5010-06 
Version: 1.0, 09/MAY/2018 
Page: Page 11 of 87 
 
7.8 
Withdrawal ............................................................................................................................... 32 
8. 
Study Design .................................................................................................................................... 33 
8.1 
Study Design ............................................................................................................................ 33 
8.2 
Allocation and Blinding ............................................................................................................. 35 
8.3 
Study Endpoints ....................................................................................................................... 35 
8.4 
Methods Used to Minimize Bias and Maximize Validity .......................................................... 36 
9. 
Study Procedures ............................................................................................................................. 37 
9.1 
Visits and Examinations ........................................................................................................... 37 
9.2 
Study Methods and Measurements ......................................................................................... 44 
9.3 
Health Economics/Quality of Life ............................................................................................. 44 
10. 
Statistical Design .............................................................................................................................. 44 
10.1 
General .................................................................................................................................... 45 
10.2 
Analysis Populations ................................................................................................................ 46 
10.3 
Baseline Data ........................................................................................................................... 46 
10.4 
Efficacy Analysis ...................................................................................................................... 46 
10.5 
Safety Analyses ....................................................................................................................... 50 
10.6 
Interim Analyses ...................................................................................................................... 50 
11. 
Sample Size Justification ................................................................................................................. 50 
12. 
Adverse Events and Device Deficiencies ........................................................................................ 51 
12.1 
Definitions ................................................................................................................................ 51 
12.2 
Reporting Procedures .............................................................................................................. 54 
12.3 
Unblinding of Investigational Product ...................................................................................... 55 
12.4 
Follow-up of Subjects with Adverse Events ............................................................................. 56 
13. 
Investigator Obligations.................................................................................................................... 56 
14. 
Sponsor and Monitor Responsibilities .............................................................................................. 57 
14.1 
Contract Research Organization ............................................................................................. 57 
14.2 
Site Qualification Visit .............................................................................................................. 57 
14.3 
Site Initiation Visit ..................................................................................................................... 57 
14.4 
Sponsor Audits and Regulatory Inspection .............................................................................. 58 
14.5 
Close-out Visit .......................................................................................................................... 58 
15. 
Protocol Amendments ...................................................................................................................... 58 
16. 
Confidentiality of the Study .............................................................................................................. 58 
17. 
Statements of Compliance ............................................................................................................... 58 
18. 
End of Study ..................................................................................................................................... 59 

 
Suturefix Ultra Suture Anchor 
Suturefix Curved Suture Anchor 
 
Prospective,  Multicenter, Post-Market  1 year Clinical  
Follow-up Study to evaluate safety and performance of 
the SUTUREFIX ULTRA and SUTUREFIX CURVED  
Suture Anchors in shoulder and hip arthroscopic repair  
Number: 17-5010-06 
Version: 1.0, 09/MAY/2018 
Page: Page 12 of 87 
 
19. 
Publication Policy ............................................................................................................................. 59 
19.1 
Publication of Study Data ......................................................................................................... 59 
19.2 
Data Sharing ............................................................................................................................ 59 
20. 
References ....................................................................................................................................... 60 
21. 
Appendices ...................................................................................................................................... 63 
21.1 
Instructions For Use Suturefix Ultra and Suturefix curved ....................................................... 63 
21.2 
Protocol Amendment ............................................................................................................... 66 
21.3 
Quality of Life Measures eQ-5D-5L ......................................................................................... 67 
21.4 
Additional assessments 27 ........................................................................................................ 69 
21.5 
Principal Investigator Obligations (ISO 14155:2011) ............................................................... 79 
3.2 
TABLE OF TABLES  
Table 9.1.1-1: Study Procedures by Visit .................................................................................................... 37 
Table 12.1-1: Categories of Adverse Event ................................................................................................ 51 
3.3 
TABLE OF FIGURES 
Figure 8.1-1: Study Flowchart ..................................................................................................................... 34 
Figure 12.3-1: Evaluation and Reporting of AE and DevD .......................................................................... 55 
 
 

 
Suturefix Ultra Suture Anchor 
Suturefix Curved Suture Anchor 
 
Prospective,  Multicenter, Post-Market  1 year Clinical  
Follow-up Study to evaluate safety and performance of 
the SUTUREFIX ULTRA and SUTUREFIX CURVED  
Suture Anchors in shoulder and hip arthroscopic repair  
Number: 17-5010-06 
Version: 1.0, 09/MAY/2018 
Page: Page 13 of 87 
 
3.4 
LIST OF ABBREVIATIONS  
Abbreviation 
Definition 
ADE 
Adverse Device Effect(s) 
AE 
Adverse Event(s) 
ASES 
American Shoulder and Elbow Surgeons Shoulder Score 
BSI 
British Standards Institute 
CAPA 
Corrective and Preventive Action 
CE 
Conformité Européene  
CI 
Confidence Interval 
CRF 
Case Report Form(s) 
CRO 
Contract Research Organization 
CT 
Computed Tomography 
CTA 
Clinical Trial Agreement 
CV 
Curriculum Vitae 
DevD 
Device Deficiency(ies) 
EQ-5D 
EuroQol 5D 
FAS 
Full Analysis Set Population 
FDA 
Food and Drug Administration 
FAI 
Femoroacetabular Impingement 
FU 
Follow-Up 
GCP 
Good Clinical Practice 
HIPAA 
Health Information Portability Accountability Act 
HHS 
Harris Hip Score 
HOOS 
Hip Disability and Osteoarthritic Outcome Scores  
HOOS-ADL 
Hip Outcome Score Activities of Daily Living 
IB 
Investigator Brochure 

Suturefix Ultra Suture Anchor 
Suturefix Curved Suture Anchor
Prospective,  Multicenter, Post-Market  1 year Clinical  
Follow-up Study to evaluate safety and performance of 
the SUTUREFIX ULTRA and SUTUREFIX CURVED  
Suture Anchors in shoulder and hip arthroscopic repair 
Number: 17-5010-06 
Version: 1.0, 09/MAY/2018 
Page: Page 14 of 87 
Abbreviation 
Definition 
ICF 
Informed Consent Form 
ICH 
International Conference on Harmonization of Technical Requirements for 
Registration of Pharmaceuticals for Human Use 
ICMJE 
International Committee of Medical Journal Editors 
IEC 
Independent Ethics Committee 
IFU 
Instructions for Use 
IP 
Investigational Product 
IRB 
Institutional Review Board 
ISF 
Investigator Site File 
ITT 
Intention to Treat population 
MDI 
Multi-directional Instability 
MITT 
Modified Intention-to-treat Population 
MRI 
Magnetic Resonance Imaging 
NA or N/A 
Not Applicable 
PI 
Principal Investigator 
PP 
Per-protocol Population 
PRO 
Subject Report Outcome 
ROWE 
ROWE Shoulder Score for Instability 
S&N 
Smith & Nephew  
SADE 
Serious Adverse Device Effect(s) 
SAE 
Serious Adverse Event(s) 
SAF 
Safety population 
SAP 
Statistical Analysis Plan 
SD 
Standard Deviation 
SLAP 
Superior Labrum Anterior-Posterior 
USADE 
Unanticipated Serious Adverse Device Effect(s) 

 
Suturefix Ultra Suture Anchor 
Suturefix Curved Suture Anchor 
 
Prospective,  Multicenter, Post-Market  1 year Clinical  
Follow-up Study to evaluate safety and performance of 
the SUTUREFIX ULTRA and SUTUREFIX CURVED  
Suture Anchors in shoulder and hip arthroscopic repair  
Number: 17-5010-06 
Version: 1.0, 09/MAY/2018 
Page: Page 15 of 87 
 
Abbreviation 
Definition 
VAS 
Visual Analogue Scale 

 
Suturefix Ultra Suture Anchor 
Suturefix Curved Suture Anchor 
 
Prospective,  Multicenter, Post-Market 1 year Clinical  
Follow-up Study to evaluate safety and performance of 
the SUTUREFIX ULTRA and SUTUREFIX CURVED  
Suture Anchors in shoulder and hip arthroscopic repair 
Number: 17-5010-06 
Version: 1.0,  09/MAY/2018 
Page: Page 16 of 87 
 
 
 
INTRODUCTION 
4.
4.1 
BACKGROUND  
Shoulder 
The superior labrum and biceps anchor improve joint stability by acting like a secondary 
stabilizer to the shoulder. Labral injuries are usually associated with anterior shoulder 
dislocation.1 Diagnosis can be established through MRI by visualizing the distinct line of 
signal contrast that lies between the glenoid’s osseous structure and the glenoid labrum.1  
SLAP (superior labrum anterior-posterior) lesions which were once mainly associated with 
overhead throwing athletes, are now being diagnosed in older populations.2 SLAP Lesions 
are classified into 4 types based on tear stability and location. SLAP tears are a detachment 
of the superior glenoid labrum from anterior to posterior with or without involvement of the 
anchor of the long head of the biceps tendon. These tears are typically the result of traction 
or compression injuries or repetitive overhead activity.3-5 
Nonoperative treatment such as physical therapy, strengthening programs, anti-
inflammatories and activity modification, should be considered prior to any surgical 
intervention.  The primary goal of conservative treatment is improvement in shoulder range 
of motion through posterior capsular flexibility and strengthening of the rotator cuff.6  When 
conservative treatment fails to improve symptoms, surgical intervention may be required. 
Surgical treatments can include simple debridement, stabilization of the biceps-labrum 
complex through repair, or biceps tenodesis.7  
Several techniques are utilized for SLAP tear repair, the most common consists of repairing 
the labrum and biceps anchor.8 The treatment methods for SLAP repair in younger 
populations as compared to older populations may vary. Older populations have reported 
pain and stiffness after SLAP repair.2 In a systematic review of the literature comparing the 
treatment in patient over 40 years to patients younger, Erickson et al.2 found similar 
outcomes in both populations after SLAP repair.  

 
Suturefix Ultra Suture Anchor 
Suturefix Curved Suture Anchor 
 
Prospective,  Multicenter, Post-Market 1 year Clinical  
Follow-up Study to evaluate safety and performance of 
the SUTUREFIX ULTRA and SUTUREFIX CURVED  
Suture Anchors in shoulder and hip arthroscopic repair 
Number: 17-5010-06 
Version: 1.0,  09/MAY/2018 
Page: Page 17 of 87 
 
 
Common complications associated with SLAP repair include hardware failure, glenoid 
osteochondrolysis, and limited range of motion. Hardware failure can include suture anchor 
pull out, or iatrogenic cartilage damage during instrumentation. Prominent suture knots or 
hardware have reportedly caused glenoid osteochondrolysis as well8. A scarce vascular 
supply to the superior labrum near the biceps where shear forces are high can contribute to 
SLAP repair failure as a result of lack of healing.8  
Outcomes of SLAP repairs have been reported good throughout the literature, with reported 
success rates ranging from 71-97%, depending on the type of implant used.3 Patients 
typically take up to 6 months to regain full motion after SLAP repairs, as stiffness is a 
common postoperative occurrence, which can be treated with physical therapy and/or 
subacromial or glenohumeral injections.3,4,8  
Return to sport is important for many patients with shoulder injuries. Typically the criteria for 
patients to return to sport include no pain, normal range of motion (ROM), near 
normal/normal strength, normal functional ability, and patient subjectivity.9 Usually 14-16 
weeks is enough for athletes to return, however it may take as long as 9-12 months.9 
Patients may be hesitant to return to sport for fear of further injury, but those with no 
restrictive symptoms should be encouraged to return to full activity.9 
The Constant score, which was developed in 1986, is also rated on a 100-point scale, of 
which 35 points are based on patient rating. This outcome measure is validated for shoulder 
arthroplasty, rotator cuff repair, adhesive capsulitis of the shoulder, and proximal humeral 
fractures. Like the ASES outcome score, higher Constant scores indicate better outcomes. 
The minimal clinically important difference for this score is not known.10 
Hip 
The labrum of the hip is a fibrocartilaginous tissue that connects to the osseous edge of the 
acetabulum, and deepens the acetabular socket while extending coverage of the femoral 
head. The labrum aids in hip stabilization, by creating negative pressure against distraction 
and increasing the resistance to dislocation.11  Femoroacetabular impingement (FAI) is an 
abnormality of the structure and orientation of the hip joint, which can cause pain and early 

 
Suturefix Ultra Suture Anchor 
Suturefix Curved Suture Anchor 
 
Prospective,  Multicenter, Post-Market 1 year Clinical  
Follow-up Study to evaluate safety and performance of 
the SUTUREFIX ULTRA and SUTUREFIX CURVED  
Suture Anchors in shoulder and hip arthroscopic repair 
Number: 17-5010-06 
Version: 1.0,  09/MAY/2018 
Page: Page 18 of 87 
 
 
hip osteoarthrosis.12-16 Skendzel et al.15 reported several retrospective reviews which have 
shown between 49-87% of all patients with a labral tear, have osseous changes consistent 
with FAI. Chondral injuries have been associated with labral tears and FAI.17 15,18 
Confirmation of FAI diagnosis usually is achieved with MRI or CT, by reviewing several 
parameters such as α angle or head-neck offset for cam-type FAI.11,18 Conservative 
treatment, such as rest, physiotherapy, and NSAIDs, is usually the first treatment option after 
FAI diagnosis.15,18,19  When conservative treatment fails to improve symptoms, surgical 
intervention may be required. Surgical treatments include debridement, repair and 
reconstruction, performed either open, arthroscopically, or mini-open.11,16,18 When labral 
repair is performed, suture anchors are typically placed onto the acetabular rim, ensuring 
they do not violate the extra-articular portion of the bone.16   
The goal of surgical intervention is to restore normal hip mechanics and treating existing 
damage. Surgical options to treat FAI include Labral debridement and/or repair.12 13,15 In an 
epidemiology study published in 2017, labral pathology was the most common diagnosis at 
82% of the population. Of the 1,124 tears reported, 75.3% were repaired, 13.7% were 
reconstructed and 7.2% were debrided.20 
In a systematic review performed by Ayeni et al.12, arthroscopic management of FAI resulted 
in postoperative improvements of modified Harris Hip scores that were greater in patients 
treated with repair as compared to debridement alone. Open management of FAI in the 
same systematic review12 reported mixed results, with one study reporting a statistically 
significant advantage of labral repair over debridement while another study identified 
reported no differences. 
Common complications reported in management of FAI included failures, reoperations, 
infection and heterotopic bone formation.12 
4.2 
LITERATURE SUMMARY 
For this literature review, a thorough analysis of the device usage was conducted for the 
SUTUREFIX ULTRA Suture and SUTUREFIX CURVED Implants equivalent devices currently 

 
Suturefix Ultra Suture Anchor 
Suturefix Curved Suture Anchor 
 
Prospective,  Multicenter, Post-Market 1 year Clinical  
Follow-up Study to evaluate safety and performance of 
the SUTUREFIX ULTRA and SUTUREFIX CURVED  
Suture Anchors in shoulder and hip arthroscopic repair 
Number: 17-5010-06 
Version: 1.0,  09/MAY/2018 
Page: Page 19 of 87 
 
 
on the market. Relevant literature was found pertaining to all indications of the SUTUREFIX 
ULTRA Suture Implant, specifically, shoulder. Good clinical outcomes were reported in the 
published literature. Improvements in Constant-Murley Scores as well as Flexilevel scale of 
shoulder function (FLEX-SF) scores were recorded. 
In 2015, Agrawal and Pietrzak21 published the first clinical study with an all-suture anchor. 
JuggerKnot 1.4 was used for the repair of triple labrum lesions. The mean number of anchors 
used in the repair was 11.5 (9-19). The study demonstrated improvement in patient outcomes, 
consistent healing of anchor tunnels, return to activity, and high patient satisfaction. The authors, 
however, stated that it is unclear whether instability rates will increase with time or there will be 
detrimental effects of placing more number of anchors in the shoulder. Radiographic results 
revealed that the JuggerKnot Soft Anchor did not hinder diagnostic imaging, and no instances of 
subchondral cysts or tunnel expansion were noted. The suture anchor tracts appeared to be 
healing with fibrous tissue.22  
Boileau et al22 reported the use of SUTUREFIX for Bankart repair in 76 patients, although no 
relevant outcomes were reported.  
No complications specific to the use of the SutureFix or Juggerknot device were reported in the 
published literature. One patient (4.34%) fell and required revision capsular shift and labrum 
repair. 22  
Shoulder 
Two clinical publications of the shoulder were identified in the literature which followed 76 patients treated 
with SutureFix and 18 patients treated with Juggerknot. 24 Mean follow up ranged from 14 to 24 months, 
with a maximum follow up of 24 months.  
 
 
 

 
Suturefix Ultra Suture Anchor 
Suturefix Curved Suture Anchor 
 
Prospective,  Multicenter, Post-Market 1 year Clinical  
Follow-up Study to evaluate safety and performance of 
the SUTUREFIX ULTRA and SUTUREFIX CURVED  
Suture Anchors in shoulder and hip arthroscopic repair 
Number: 17-5010-06 
Version: 1.0,  09/MAY/2018 
Page: Page 20 of 87 
 
 
Hip 
One clinical publication was identified which used the JuggerKnot device in the hip. Matsuda et 
al., 201523 performed a prospective comparative study to compare arthroscopic treatment of 
global versus focal pincer FAI using a JuggerKnot anchor. The global group consisted of 15 
patients (18 hips) and the focal group consisted of 125 patients (129 hips) with a minimum of 2-
year follow up. Labral refixation of the posterior rim was performed with a JuggerKnot anchor, it 
is mentioned that a curved guide was used on occasion, but the number of patients treated with 
curved devices was not reported.  
4.3 
STUDY PURPOSE 
This is a prospective, multicenter study to evaluate intra-operative, 6 and 12-month safety and 
performance of the SUTUREFIX ULTRA and SUTUREFIX CURVED Suture Anchors for 
arthroscopic soft tissue repair to meet PMCF requirements for CE Mark and Notified Body (BSI) 
when used for any of the following indications: 
Hip 
• 
Acetabular labrum repair/reconstruction 
Shoulder 
• 
Capsular stabilization 
 
Bankart repair 
 
Anterior shoulder instability 
 
SLAP lesion repairs 
 
Capsular shift or capsulolabral reconstructions 
• 
Rotator cuff tear repairs 
• 
Biceps tenodesis 
• 
Acromioclavicular separation repairs 
• 
Deltoid repairs 

 
Suturefix Ultra Suture Anchor 
Suturefix Curved Suture Anchor 
 
Prospective,  Multicenter, Post-Market 1 year Clinical  
Follow-up Study to evaluate safety and performance of 
the SUTUREFIX ULTRA and SUTUREFIX CURVED  
Suture Anchors in shoulder and hip arthroscopic repair 
Number: 17-5010-06 
Version: 1.0,  09/MAY/2018 
Page: Page 21 of 87 
 
 
4.4 
SAFETY CONSIDERATIONS 
The SUTUREFIX ULTRA and SUTUREFIX CURVED Anchor Systems are intended to be used 
for soft tissue to bone fixation in the Shoulder and Hip. Representative language of the 
contraindications and potential adverse effects from SUTUREFIX ULTRA and SUTUREFIX 
CURVED can be found in the IFU. Cleaning and Sterilization Language can be found on the 
Reusable Surgical Instruments IFU. 
Possible Anticipated Adverse Device Effect (ADE) and anticipated Serious Adverse Device 
Effect (SADE) as reported in the IFU are: 
• 
Mild inflammatory reaction 
• 
Foreign body reaction 
• 
Infection, both deep and superficial 
• 
Allergic reaction 
• 
Loss of fixation or pullout of suture anchors can occur 
Investigators shall record adverse events (AEs) and observed device deficiencies, together with 
an assessment, in the subject’s source data. Investigators are responsible for documenting AEs 
(AE, ADE, SAE, SADE) as described in section 12.1.1 and device deficiencies on the 
appropriate CRF and submitting them to the Sponsor according to the timelines described here 
below. At each contact with the subject, the Investigator must seek information on AEs by 
specific questioning and, as appropriate, by assessment of the subject. AEs must be recorded in 
standard English medical terminology.  
Unresolved AEs should be followed by the Investigator until the events are resolved, the subject 
is lost to follow-up or through to the end of the study, whichever timing occurs first. Unresolved 
AEs at the end of the subject’s participation will be monitored by the Investigator as part of the 
site’s normal standard of care. 

 
Suturefix Ultra Suture Anchor 
Suturefix Curved Suture Anchor 
 
Prospective,  Multicenter, Post-Market 1 year Clinical  
Follow-up Study to evaluate safety and performance of 
the SUTUREFIX ULTRA and SUTUREFIX CURVED  
Suture Anchors in shoulder and hip arthroscopic repair 
Number: 17-5010-06 
Version: 1.0,  09/MAY/2018 
Page: Page 22 of 87 
 
 
 
OBJECTIVE(S) 
5.
5.1 
PRIMARY OBJECTIVE 
The purpose of this study is to demonstrate the safety and performance of the SUTUREFIX 
ULTRA and SUTUREFIX CURVED Suture Anchors in hip and shoulder arthroscopic repair over 
a time period of 12 months after arthroscopy. 
5.1.1 Primary Endpoint  
To assess clinical success rate, defined as subjects without signs of failure and/or re-
intervention at 6 months, as assessed by the surgeon. 
5.2 
SECONDARY OBJECTIVE(S) 
5.2.1 Secondary Endpoints 
To assess safety and performance, supporting the use of SUTUREFIX ULTRA and SUTUREFIX 
CURVED Suture Anchor in hip and shoulder arthroscopy repair by measuring: 
• 
Clinical success rate, defined as subjects without signs of failure and/or re-intervention at 
12 months, as assessed by the surgeon 
• 
Intra-operative anchor deployment success rate 
• 
Number of anchors pulled out 
• 
Use of additional anchors as a result of intra-operative failure 
• 
Device-related re-intervention 
• 
Safety evaluation at all time points 
• 
Post-operative clinical success rate and performance assessed with subject reported 
outcomes as follows: 
All subjects: 
• 
Subject pain assessment with VAS at 6 months* and 12 months* 

 
Suturefix Ultra Suture Anchor 
Suturefix Curved Suture Anchor 
 
Prospective,  Multicenter, Post-Market 1 year Clinical  
Follow-up Study to evaluate safety and performance of 
the SUTUREFIX ULTRA and SUTUREFIX CURVED  
Suture Anchors in shoulder and hip arthroscopic repair 
Number: 17-5010-06 
Version: 1.0,  09/MAY/2018 
Page: Page 23 of 87 
 
 
• 
Subject satisfaction assessment with VAS at 6 months* and 12 months* 
• 
EQ-5D Questionnaire at 6 months* and 12 months* 
Hip subjects: 
• 
Hip Outcome Score Activities of Daily Living (HOOS-ADL) at 6 months* and 12 months* 
• 
Modified Harris Hip Score (HHS) at 6 months* and 12 months* 
Shoulder subjects: 
• 
ROWE Shoulder Scores at 6 months* and 12 months* 
• 
ASES Shoulder Scores at 6 months* and 12 months* 
• 
Constant-Murley Shoulder Scores at 6 months* and 12 months* 
* Patient Reported Outcomes (PROs) are optional and used according to the surgeon’s 
preference 
 
INVESTIGATIONAL PRODUCT(S) 
6.
6.1.1 Investigational Products 
The SUTUREFIX Anchor is offered in multiple suture configurations including single and double 
loaded suture options. The delivery system of these anchors enables the suture implant to be 
placed in the bone in an un- deployed state. During anchor deployment, tension is applied to 
the repair sutures. The tension applied to the repair sutures, which are threaded through the 
anchor suture, cause the anchor suture to bunch up. In its deployed state the anchor has a 
larger nominal diameter than the hole in which it is inserted, locking it into the bone tunnel 
(Figure 1). The implanted suture anchor construct retains mechanical stability of the soft tissue 
to bone construct during the healing period. The anchors are available preloaded with either 
one #2 suture or two #1 sutures.  

 
Suturefix Ultra Suture Anchor 
Suturefix Curved Suture Anchor 
 
Prospective,  Multicenter, Post-Market 1 year Clinical  
Follow-up Study to evaluate safety and performance of 
the SUTUREFIX ULTRA and SUTUREFIX CURVED  
Suture Anchors in shoulder and hip arthroscopic repair 
Number: 17-5010-06 
Version: 1.0,  09/MAY/2018 
Page: Page 24 of 87 
 
 
The anchor suture is composed of a single strand of #5 braided, silicone-coated, polyester, non-
absorbable suture marketed under the trade name DURABRAID™. The repair suture is 
comprised of non-absorbable, uncoated ultra-high molecular weight polyethylene (UHMWPE) 
marketed under the trade name ULTRABRAID™. 
 
 
 
 
 
  
 
 
Figure 1. SUTUREFIX Implant 
 
 
 
 
 
      Figure 2. SUTUREFIX ULTRA                                          Figure 3. SUTUREFIX ULTRA DRILL 
 
The SUTUREFIX ULTRA Suture Anchor consists of three components; an all suture based 
implant preloaded onto a rigid insertion device (Figure 2 and 3), hole preparation and insertion 
accessory instruments. The Smith & Nephew SUTUREFIX CURVED Suture Anchor utilizes the 
same anchor as the SUTUREFIX ULTRA (Figure 1), however it comes preassembled to a 
flexible insertion device (Figure 4 and 5). These devices are provided sterile, for single use 
only. 
 

 
Suturefix Ultra Suture Anchor 
Suturefix Curved Suture Anchor 
 
Prospective,  Multicenter, Post-Market 1 year Clinical  
Follow-up Study to evaluate safety and performance of 
the SUTUREFIX ULTRA and SUTUREFIX CURVED  
Suture Anchors in shoulder and hip arthroscopic repair 
Number: 17-5010-06 
Version: 1.0,  09/MAY/2018 
Page: Page 25 of 87 
 
 
 
 
 
 
     Figure 4. SUTUREFIX CURVED                                     Figure 5. SUTUREFIX CURVED DRILL 
 
The instruments included in this file consist of single-use sterile drills (rigid and flexible), as 
well as reusable drill guides (straight and curved) and obturators (rigid and flexible) (examples 
seen below in Figures 4 and 5). 
 
 
 
 
 
    Figure 6. Straight obturator and twist drill               Figured 7. Curved Drill Guide 
 
The devices included in this file do not contain any medicinal substances, tissues or blood 
products. 
 

 
Suturefix Ultra Suture Anchor 
Suturefix Curved Suture Anchor 
 
Prospective,  Multicenter, Post-Market 1 year Clinical  
Follow-up Study to evaluate safety and performance of 
the SUTUREFIX ULTRA and SUTUREFIX CURVED  
Suture Anchors in shoulder and hip arthroscopic repair 
Number: 17-5010-06 
Version: 1.0,  09/MAY/2018 
Page: Page 26 of 87 
 
 
6.1.2 IP-Control system tells you when the anchor has deployed via audible,  
This is the list of study components. 
 
 
 

 
Suturefix Ultra Suture Anchor 
Suturefix Curved Suture Anchor 
 
Prospective,  Multicenter, Post-Market 1 year Clinical  
Follow-up Study to evaluate safety and performance of 
the SUTUREFIX ULTRA and SUTUREFIX CURVED  
Suture Anchors in shoulder and hip arthroscopic repair 
Number: 17-5010-06 
Version: 1.0,  09/MAY/2018 
Page: Page 27 of 87 
 
 
6.1.3 Ancillary Products 
No ancillary products are to be provided. 
6.2 
PRODUCT USE 
SUTUREFIX ULTRA and CURVED Suture Anchors are intended for the secure fixation of soft 
tissue to bone and should be used according to IFU. The non-absorbable suture will remain in 
the tissue permanently.  
Surgeons selected to participate in this study will be experienced with implanting SUTUREFIX 
ULTRA Suture Anchor and SUTUREFIX CURVED Suture Anchor and no additional training is 
required. 
6.3 
PACKAGING AND LABELLING 
Packaging and labelling will be prepared to meet regulatory requirements. 
Commercial products are being used and the standard device procurement and management 
will be used per site process.  
Packaging integrity needs to be confirmed prior to surgery and recorded in the CRF. 
6.4 
IP/ ANCILLARY PRODUCTS AND STUDY SUPPLIES ACCOUNTABILITY PROCEDURES  
This is a post-market follow-up study. Only commercial available devices are implanted by the 
hospitals or clinics. All products received regulatory clearance in the countries where the study 
takes place. Therefore no device accountability is applicable. 
6.5 
SURGICAL TECHNIQUE 
All study related procedures with the SUTUREFIX Ultra Suture Anchor and SUTUREFIX Curved 
Suture Anchor must be performed according to the recommended surgical technique described 

Suturefix Ultra Suture Anchor 
Suturefix Curved Suture Anchor
Prospective,  Multicenter, Post-Market 1 year Clinical  
Follow-up Study to evaluate safety and performance of 
the SUTUREFIX ULTRA and SUTUREFIX CURVED  
Suture Anchors in shoulder and hip arthroscopic repair
Number: 17-5010-06 
Version: 1.0,  09/MAY/2018 
Page: Page 28 of 87 
in the protocol or in a separate instructional document and product labelling (e.g. IFU and 
package insert) as applicable. 
 
SUBJECT ENROLLMENT AND WITHDRAWAL 
7.
7.1 
SUBJECT POPULATION 
In this study a minimum of 80 subjects will be enrolled, 40 subjects for each group, hip and 
shoulder. The subjects will be treated with the study device(s) for hip or shoulder instability. 
7.2 
INCLUSION CRITERIA 
Subjects will be considered qualified for enrollment if they meet the following criteria: 
1. 
2. 
3. 
4. 
5. 
6. 
7 
8. 
Subject has consented to participate in the study by signing the EC-approved informed 
consent form  
Subject is 18 years of age at time of surgery. 
Subject condition meets proposed indication to SUTUREFIX ULTRA and SUTUREFIX 
CURVED  Suture Anchor 
Subject requiring shoulder or hip arthroscopic labral repair surgery from physical 
findings, subject symptoms and radiographic finding 
Bone quality and quantity must be adequate to allow proper placement of the anchor 
Able to follow instructions. 
Willing and able to make all required study visits. 
Hip subjects 
FAI (Femoroacetabular Impingement) 
Shoulder subjects 
9.
Subject with a history of recurrent dislocation/subluxation of the shoulder

Suturefix Ultra Suture Anchor 
Suturefix Curved Suture Anchor
Prospective,  Multicenter, Post-Market 1 year Clinical  
Follow-up Study to evaluate safety and performance of 
the SUTUREFIX ULTRA and SUTUREFIX CURVED  
Suture Anchors in shoulder and hip arthroscopic repair
Number: 17-5010-06 
Version: 1.0,  09/MAY/2018 
Page: Page 29 of 87 
7.3 
EXCLUSION CRITERIA 
Any one (1) of the following criteria will disqualify a potential subject from participation in the 
study: 
1. 
All subjects 
Participation in the treatment period of another clinical trial within thirty (30) days of Visit 
1 (pre-operative)  
2 
Women who are pregnant, nursing, or of child-bearing potential who are not utilizing 
highly effective birth control measures  
3.
Any subject that meets the definition of a Vulnerable Subject per ISO14155:2011:
individual whose willingness to volunteer in a clinical investigation could be unduly
influenced by the expectation, whether justified or not, of benefits associated with
participation or of retaliatory response from senior members of a hierarchy in case of
refusal to participate
4.
Subjects with a history of poor compliance with medical treatment
5.
Contraindications or hypersensitivity to the use of the SUTUREFIX ULTRA and/or
SUTUREFIX CURVED Suture Anchor, or their components (e.g. silicone, polyester).
Where material sensitivity is suspected, appropriate tests should be performed and
sensitivity ruled out prior to implantation
6.
Prior ipsilateral surgeries performed on the joint space

Suturefix Ultra Suture Anchor 
Suturefix Curved Suture Anchor
Prospective,  Multicenter, Post-Market 1 year Clinical  
Follow-up Study to evaluate safety and performance of 
the SUTUREFIX ULTRA and SUTUREFIX CURVED  
Suture Anchors in shoulder and hip arthroscopic repair
Number: 17-5010-06 
Version: 1.0,  09/MAY/2018 
Page: Page 30 of 87 
8. 
9. 
10. 
11. 
12. 
13.
14. 
15. 
Pathological conditions of bone, such as cystic changes or severe osteopenia, which 
would compromise secure anchor fixation 
Pathological conditions in the soft tissues to be attached that would impair secure 
fixation by suture 
Comminuted bone surface, which would compromise secure anchor fixation 
Physical conditions which would eliminate, or tend to eliminate, adequate anchor 
support in impair healing 
Epileptic history 
Hip subjects 
Dysplasia latera/central less than 20° 
Shoulder subjects 
Glenoid and/or humeral bone loss considered excessive by the treating orthopaedic 
surgeon 
MDI: Multi-directional instability
Psychosomatic voluntary shoulder subluxation 
7.4 
SCREENING
To eliminate the potential for selection bias, Investigators should consecutively pre-screen all 
subjects undergoing arthroscopic instability repair with SUTUREFIX ULTRA Suture Anchor 
and/or SUTUREFIX CURVED Suture Anchor.  Subjects receiving care at the investigative sites 
will be pre-screened as potential subjects for the study. To do so, only the existing information 
obtained per standard routine medical procedures will be used. No study-specific screening 
procedures, activities or questionnaires will be performed during pre-screening. 
Participating study sites are required to document all screened subjects considered for inclusion 
in this study. If a subject is excluded from the study, the reasons for exclusion will be 
documented in the subject's source documents and noted on the Screening and Enrollment Log.  

 
Suturefix Ultra Suture Anchor 
Suturefix Curved Suture Anchor 
 
Prospective,  Multicenter, Post-Market 1 year Clinical  
Follow-up Study to evaluate safety and performance of 
the SUTUREFIX ULTRA and SUTUREFIX CURVED  
Suture Anchors in shoulder and hip arthroscopic repair 
Number: 17-5010-06 
Version: 1.0,  09/MAY/2018 
Page: Page 31 of 87 
 
 
Once a subject has completed the informed consent procedure and signed an Ethics Committee 
approved Informed Consent Form (ICF), the PI or delegated study research staff can complete 
the screening process with the subject (see Section 9.1).  
All screening activities which occur prior to consent shall be referred to as pre-screening.  
7.5 
INFORMED CONSENT 
Before conducting any study procedures or examinations, the purpose and nature of the study 
will be explained to the subject in their native language. The ICF will be translated from English 
master ICF and/or adjusted to the EC requirements to the national languages of the participating 
European countries.  The subject, or their legally authorized representative, will then read, sign, 
and personally date the IRB/IEC-approved informed consent document(s) (see below for 
difficulties with reading and writing). Additionally, the individual who obtains consent from the 
subject will sign and date the informed consent document. A copy of the signed informed 
consent documentation will be provided to the subject, a copy will be placed in the subject’s 
medical record, with the original filed in the ISF. 
If the subject is unable to read, the informed consent document and associated study 
information may be read aloud to the subject in the presence of an impartial witness. If possible 
the subject shall sign and personally date the Informed Consent Form (ICF). Where this is not 
possible, due to difficulties in writing, the subject shall provide verbal consent to participate in the 
study. The witness shall then personally sign and date the informed consent form, attesting that 
the information was accurately explained and that the informed consent was freely given. 
For the site(s) in United States the HIPPA requirements will be in place. 

 
Suturefix Ultra Suture Anchor 
Suturefix Curved Suture Anchor 
 
Prospective,  Multicenter, Post-Market 1 year Clinical  
Follow-up Study to evaluate safety and performance of 
the SUTUREFIX ULTRA and SUTUREFIX CURVED  
Suture Anchors in shoulder and hip arthroscopic repair 
Number: 17-5010-06 
Version: 1.0,  09/MAY/2018 
Page: Page 32 of 87 
 
 
7.6 
ENROLLMENT 
Once a subject has completed the informed consent procedure and signed an Ethics Committee 
approved Informed Consent Form (ICF) the PI or delegated study research staff can complete 
the screening process with the subject. 
7.7 
LOST TO FOLLOW-UP 
Some actively enrolled subjects will not return for follow-up exams on time. Study personnel 
must make a reasonable effort to contact the subject and document the following contact 
attempts prior to declaring a subject to be lost to follow-up: the subject has been contacted 
according to the site's policies, but no fewer than 2 documented phone contacts and 1 certified 
letter without response. Copies of all attempts to reach the subjects per regular mail or email 
and/or the attempts to contact the subject via other means should be documented and that 
documentation should be kept with the subject’s source documents. 
7.8 
WITHDRAWAL 
7.8.1 Withdrawal from Treatment 
Not applicable 
7.8.2 Withdrawal from Study 
The Investigator may withdraw subjects from the study for many reasons, including but not 
limited to the following: 
• 
subject noncompliance (e.g. did not follow instructions) 
• 
subject lost to follow-up 
• 
if the Investigator or the Sponsor stops the study for any reason and decides to withdraw 
subject(s) from the study 
• 
Adverse Events/ 

Suturefix Ultra Suture Anchor 
Suturefix Curved Suture Anchor
Prospective,  Multicenter, Post-Market 1 year Clinical  
Follow-up Study to evaluate safety and performance of 
the SUTUREFIX ULTRA and SUTUREFIX CURVED  
Suture Anchors in shoulder and hip arthroscopic repair
Number: 17-5010-06 
Version: 1.0,  09/MAY/2018 
Page: Page 33 of 87 
•
any other significant reason identified by the Investigator
For each case, information will be obtained in the source document and the Case Report Form 
(CRF) detailing circumstances leading to the withdrawal.  
Subjects who drop out or are withdrawn will not be re-entered into the study at a later date. 
7.8.3 Subject’s Withdrawal of Consent to Participate in Study 
Study participation is voluntary and subjects may withdraw at any point during the study without 
giving their reason for doing so. Where subjects withdraw consent, the Investigator should make 
a reasonable effort to ascertain the reason(s), while fully respecting the subject’s privacy. The 
reason for withdrawal will be recorded in the CRF and in source documents. 
7.8.4 Use of Data Following Withdrawal 
In cases where the subject withdraws consent, the data collected up to the point of withdrawal 
may be used but no additional data for that subject may be collected.  
8. 
STUDY DESIGN
8.1 
STUDY DESIGN 
This is a prospective, multicenter study to evaluate the clinical and intraoperative outcomes from 
80 subjects implanted with the SUTUREFIX ULTRA and/or SUTUREFIX CURVED Suture 
Anchors in hip or shoulder groups. Up to 8 sites (up to 4 sites for study hip group and up to 4 
sites for study shoulder group) in Europe will participate in the study. Data from eligible 
subjects, who have provided written and informed consent for the collection of their coded data 
(see section 9.1.2-9.1.6) will be recorded from the subject medical file on Case Report 
Forms (CRFs). Follow-up clinical assessments will be performed at 6 months and 1 year post-
operatively.  

 
Suturefix Ultra Suture Anchor 
Suturefix Curved Suture Anchor 
 
Prospective,  Multicenter, Post-Market 1 year Clinical  
Follow-up Study to evaluate safety and performance of 
the SUTUREFIX ULTRA and SUTUREFIX CURVED  
Suture Anchors in shoulder and hip arthroscopic repair 
Number: 17-5010-06 
Version: 1.0,  09/MAY/2018 
Page: Page 34 of 87 
 
 
This is an open-label study with consecutive enrollment. The study will continue for 12 months 
from the date of treatment for the last subject completing the study as planned. Only subjects 
who meet the enrollment criteria as listed in section 7 will be enrolled into the study. The study 
duration is planned for 24 months. 
The data will support CE Mark certification for the Shoulder and Hip repair indications. The data 
should confirm safety and performance levels acceptable for the risk benefit profile of this 
device. 
 
Figure 8.1-1: Study Flowchart 
 
 
 
                                                yes 
 
 
no  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
        yes 
 
 
 
 
 
 
      
 
 
 
 
 
 
      no 
 
 
 
 
 
 
 
Pre-Screening 
Screening 
Enrollment and Study Conduct 
Verification of eligibility criteria 
per standard routine medical 
procedure: 
 
Subject eligible?  
Complete Informed Consent Procedure 
Subject willing to participate? 
 
No further action 
 
Document subject on screening and 
enrollment log 
 
 
Update screening and enrollment log. No 
CRFs will be collected 
Perform Assessment 1: Pre-operative 
visit and complete pre-operative CRFs 
Perform Assessment 2: Surgery and 
complete intra-operative and discharge 
CRFs 
Perform Assessment 3: 6-months follow-
up visit and complete CRFs 
Perform Assessment 4: 12-months 
follow-up call and complete CRFs 

Suturefix Ultra Suture Anchor 
Suturefix Curved Suture Anchor
Prospective,  Multicenter, Post-Market 1 year Clinical  
Follow-up Study to evaluate safety and performance of 
the SUTUREFIX ULTRA and SUTUREFIX CURVED  
Suture Anchors in shoulder and hip arthroscopic repair
Number: 17-5010-06 
Version: 1.0,  09/MAY/2018 
Page: Page 35 of 87 
8.2 
ALLOCATION AND BLINDING 
This study is an open-label study with consecutive enrolment without randomization. There is no 
control group. Although there are two groups one hip and one shoulder group blinding of the 
surgeon is not applicable due to the different indications and product specificities. The evaluator 
will be blinded to the treatment groups. 
8.3 
STUDY ENDPOINTS 
8.3.1 Primary Endpoint 
•
Clinical success rate, defined as subjects without signs of failure and/or re-intervention 
at 6 months, as assessed by the surgeon 
8.3.2 Secondary Endpoints 
•
Clinical success rate, defined as subjects without signs of failure and/or re-intervention
at 12 months, as assessed by the surgeon
•
Intra-operative anchor deployment success rate
•
Number of anchors pulled out
•
Use of additional anchors as a result of intra-operative failure
•
Device-related re-intervention
•
Safety evaluation at all time points
•
Post-operative clinical success rate and performance assessed with subject reported
outcomes as follows:
All subjects: 
•
Subject pain assessment with VAS at 6 months* and 12 months*
•
Subject satisfaction assessment with VAS at 6 months* and 12 months*
•
EQ-5D Questionnaire at 6 months* and 12 months*

 
Suturefix Ultra Suture Anchor 
Suturefix Curved Suture Anchor 
 
Prospective,  Multicenter, Post-Market 1 year Clinical  
Follow-up Study to evaluate safety and performance of 
the SUTUREFIX ULTRA and SUTUREFIX CURVED  
Suture Anchors in shoulder and hip arthroscopic repair 
Number: 17-5010-06 
Version: 1.0,  09/MAY/2018 
Page: Page 36 of 87 
 
 
Hip subjects: 
• 
Hip Outcome Score Activities of Daily Living (HOOS-ADL) at 6 months* and 12 months* 
• 
Modified Harris Hip Score (HHS) at 6 months* and 12 months* 
Shoulder subjects: 
• 
ROWE Shoulder Scores at 6 months* and 12 months* 
• 
ASES Shoulder Scores at 6 months* and 12 months* 
• 
Constant-Murley Shoulder Scores at 6 months* and 12 months* 
* Patient Reported Outcomes (PROs) are optional and used according to the surgeon’s 
preference 
8.4 
METHODS USED TO MINIMIZE BIAS AND MAXIMIZE VALIDITY 
The study is a prospective multi-centre non-comparative cohort study to demonstrate the 
performance of the SUTUREFIX ULTRA and SUTUREFIX CURVED Suture Anchors in hip and 
shoulder for arthroscopic treatment over a time period of 12 months after arthroscopy. The study 
is exploratory in nature and not powered for any statistical testing hence the results from the 
study will be interpreted with caution. 
Biases naturally associated with exploratory non-comparative studies will be inevitable but the 
use of multiple recruitment centres and well defined inclusion/exclusion criteria ensures that the 
study is more representative of a larger population and varying backgrounds. The exploratory 
data analysis planned for the study which includes confidence intervals for the outcome 
summaries, a pre-defined confidence interval for the primary outcome and exploratory statistical 
models adjusting for potential confounding factors is designed to maximise the validity of the 
study results. 
 

 
Suturefix Ultra Suture Anchor 
Suturefix Curved Suture Anchor 
 
Prospective,  Multicenter, Post-Market 1 year Clinical  
Follow-up Study to evaluate safety and performance of 
the SUTUREFIX ULTRA and SUTUREFIX CURVED  
Suture Anchors in shoulder and hip arthroscopic repair 
Number: 17-5010-06 
Version: 1.0,  09/MAY/2018 
Page: Page 37 of 87 
 
 
 
STUDY PROCEDURES 
9.
9.1 
VISITS AND EXAMINATIONS  
9.1.1 Summary 
For a summary of the required procedures by visit, refer to Table 9.1-1: Study Procedures by 
Visit 
Table 9.1.1-1: Study Procedures by Visit 
Schedule of events (*as needed) 
 
Visit 1 
 
Visit 2 
 
Visit 3 
Visit 
Visit 4 
Telephone 
Call or Visit 
Visit 5 
Unscheduled 
Visit 
Pre-
Operative 
Operative 
through 
Discharge 
6 Months 
(± 1 M) 
12 Months 
(± 1 M) 
 
Informed Consent 
√ 
 
 
 
 
Inclusion/Exclusion Criteria 
√ 
 
 
 
 
Demographics/ Medical  History 
√ 
 
 
 
 
Intra-op failure as assessed by the 
surgeon 
 
√ 
 
 
 
Operative through Discharge  
 
√ 
 
 
 
Post-op Repair failure 
 
 
√ 
√ 
√ 
All subjects 
Pain assessment with VAS 
 
√** 
 
 
√** 
 
√** 
 
√** 
Satisfaction assessment with VAS 
√** 
 
√** 
√** 
√** 
EQ-5D questionnaire 
√** 
 
√** 
√** 
√** 
Hip 
HOOS-ADL score 
 
√** 
 
√** 
√** 
√** 
Mod. Harris Hip score 
√** 
 
√** 
√** 
√** 
Shoulder 
ROWE score  
√** 
 
√** 
√** 
√** 
ASES score 
√** 
 
√** 
√** 
√** 

 
Study Protocol—Device 
Prospective,  Multicenter, Post-Market Clinical  Follow-
up Study to evaluate safety and performance of the 
SUTUREFIX ULTRA and SUTUREFIX CURVED  Suture 
Anchors in shoulder and hip arthroscopic repair 
Number: 17-5010-06 
Version: 0.17, 
17/APR/2018 
Page: Page 38 of 87 
 
 
Schedule of events (*as needed) 
 
Visit 1 
 
Visit 2 
 
Visit 3 
Visit 
Visit 4 
Telephone 
Call or Visit 
Visit 5 
Unscheduled 
Visit 
Pre-
Operative 
Operative 
through 
Discharge 
6 Months 
(± 1 M) 
12 Months 
(± 1 M) 
 
Constant-Murley score 
√** 
 
√** 
√** 
√** 
MRI / Imaging 
√ 
 
√* 
√* 
√* 
Adverse Event Assessment 
 
√ 
√ 
End of Study/Exit   
 
 
√ 
 
* If needed to investigate repair failure 
 
** Patient Reported Outcomes (PROs) are optional and used according to the surgeon’s preference 

 
Study Protocol—Device 
Prospective,  Multicenter, Post-Market Clinical  Follow-
up Study to evaluate safety and performance of the 
SUTUREFIX ULTRA and SUTUREFIX CURVED  Suture 
Anchors in shoulder and hip arthroscopic repair 
Number: 17-5010-06 
Version: 1.0, 09/MAY/2018 
Page: Page 39 of 87 
 
 
9.1.2 Visit 1: Pre-Operative Visit  
 
• 
Obtain written informed consent from the subject as detailed in Section 7.5 
----- Do not proceed until consent has been obtained ----- 
 
• 
Obtain demographic information and medical history, including information on all 
concomitant medications/therapies 
 
• 
Screen the subject for protocol inclusion/exclusion criteria 
• 
Assign the subject a study number and instruct the subject on treatment procedures 
• 
Complete Screening and Enrollment Log 
 
• 
Complete VAS-Scale for Pain  for all subjects* 
• 
Complete EQ-5D questionnaire for all subjects* 
• 
Complete ROWE Score for shoulder* 
• 
ASES Score for shoulder* 
• 
Complete Constant-Murley Score for shoulder* 
• 
Complete HOOS-ADE Score for hip* 
• 
Complete Modified HSS Sore for hip* 
• 
Perform MRI, only in case of repair failure 
 
 
 
 
 
 
 
 
 
 
 
• 
If any adverse events are observed or reported, they must be recorded as instructed 
in Section 12.3, adverse events and device deficiencies 
• 
Complete Pre-Operative Visit CRFs 
 
*Patient Reported Outcomes (PROs) are optional and used according to the surgeon’s 
preference. 

 
Study Protocol—Device 
Prospective,  Multicenter, Post-Market Clinical  Follow-
up Study to evaluate safety and performance of the 
SUTUREFIX ULTRA and SUTUREFIX CURVED  Suture 
Anchors in shoulder and hip arthroscopic repair 
Number: 17-5010-06 
Version: 1.0, 09/MAY/2018 
Page: Page 40 of 87 
 
 
9.1.3 Visit 2: Operation through Discharge Visit  
• 
Query subject regarding any changes in general health and the use of concomitant 
medications 
• 
If any adverse device effects or device deficiencies are observed or reported, they 
must be recorded as instructed in Section 12.3 adverse events and device 
deficiencies 
• 
Update information in the Screening and Enrollment Log 
• 
Intra-operative success as assessed by the surgeon 
• 
MRI/Images, only in case of repair failure 
• 
Complete Operation and Discharge Visit CRFs 
• 
Instruct the subject on follow-up procedures, including returning to the facility for FU 
Visit 3 in (± 1M) 6 months 
 
 
9.1.4 Visit 3: 6-Month Follow-up Visit (± 1 month) 
• 
Query subject regarding any changes in general health and the use of concomitant 
medications. 
• 
If any adverse device effects or device deficiencies are observed or reported, they 
must be recorded as instructed in Section 12.3, adverse events and device 
deficiencies 
• 
Post-operative repair failure 
• 
Complete VAS-Scale for Pain and Satisfaction for all subjects* 
• 
Complete EQ-5D questionnaire for all subjects* 
• 
Complete ROWE Score for shoulder* 
• 
ASES Score for shoulder* 
• 
Complete Constant-Murley Score for shoulder* 
• 
Complete HOOS-ADE Score for hip* 

Study Protocol—Device 
Prospective,  Multicenter, Post-Market Clinical  Follow-
up Study to evaluate safety and performance of the 
SUTUREFIX ULTRA and SUTUREFIX CURVED  Suture 
Anchors in shoulder and hip arthroscopic repair 
Number: 17-5010-06 
Version: 1.0, 09/MAY/2018 
Page: Page 41 of 87 
•
Complete Modified HSS Sore for hip*
•
Perform MRI/Imaging only in case of repair failure
•
Complete 6-Months Follow-up Visit CRFs
•
Instruct the subject on follow-up procedures, including scheduling a FU call or
visit  in (± 1M) 12 months
*Patient Reported Outcomes (PROs) are optional and used according to the surgeon’s
preference.
9.1.5 Visit 4: 12-Months Follow-up Call or Visit (± 1 month) 
•
Query subject regarding any changes in general health and the use of concomitant
medications.
•
If any adverse device effects or device deficiencies are observed or reported, they
must be recorded as instructed in Section 12.3, adverse events and device
deficiencies.
•
Post-operative repair failure
•
Complete VAS-Scale for Pain and Satisfaction for all subjects*
•
Complete EQ-5D questionnaire for all subjects*
•
Complete ROWE Score for shoulder*
•
ASES Score for shoulder*
•
Complete Constant-Murley Score for shoulder*
•
Complete HOOS-ADE Score for hip*
•
Complete Modified HSS Sore for hip*
•
Perform MRI/Imaging only in case of repair failure
*Patient Reported Outcomes (PROs) are optional and used according to the surgeon’s
preference.

Study Protocol—Device 
Prospective,  Multicenter, Post-Market Clinical  Follow-
up Study to evaluate safety and performance of the 
SUTUREFIX ULTRA and SUTUREFIX CURVED  Suture 
Anchors in shoulder and hip arthroscopic repair 
Number: 17-5010-06 
Version: 1.0, 09/MAY/2018 
Page: Page 42 of 87 
9.1.6 Unscheduled Visits 
•
Query subject regarding any changes in general health and the use of concomitant
medications.
•
Adverse device effects or device deficiencies must be recorded as instructed in
Section 12.3, adverse events and device deficiencies.
•
Post-operative repair failure
•
Complete VAS-Scale for Pain and Satisfaction for all subjects*
•
Complete EQ-5D questionnaire for all subjects*
•
Complete ROWE Score for shoulder*
•
ASES Score for shoulder*
•
Complete Constant-Murley Score for shoulder*
•
Complete HOOS-ADE Score for hip*
•
Complete Modified HSS Sore for hip*
•
Perform MRI/Imaging to investigate repair failure
•
Complete Unscheduled Visit CRFs
*Patient Reported Outcomes (PROs) are optional and used according to the
surgeon’s preference
Unscheduled examinations may be conducted at the discretion of the Investigator with all 
obtained information recorded in the source documents and on the appropriate CRF. 
9.1.7 Concomitant Medications and Therapies 
A concomitant medication (e.g. drug, substance) and a concomitant therapy (e.g. physical 
therapy, TENS Unit, massage) are recorded at any time from enrollment into the study through 
the subject’s last study visit.  

 
Study Protocol—Device 
Prospective,  Multicenter, Post-Market Clinical  Follow-
up Study to evaluate safety and performance of the 
SUTUREFIX ULTRA and SUTUREFIX CURVED  Suture 
Anchors in shoulder and hip arthroscopic repair 
Number: 17-5010-06 
Version: 1.0, 09/MAY/2018 
Page: Page 43 of 87 
 
 
9.1.7.1 
Concomitant Medications 
9.1.7.1.1 
Excluded Concomitant Medications 
Not applicable 
9.1.7.1.2 
Recording Concomitant Medications in the CRF 
Concomitant medications should be recorded in the CRF with the generic name. 
9.1.7.2 
Concomitant Therapies 
9.1.7.2.1 
Therapies Prohibited During the Study  
Not applicable 
9.1.7.2.2 
Recording Concomitant Therapies in the CRF 
Standard concomitant therapy will be recorded in the CRF unless provided as a part of an AE 
treatment. 
9.1.8 Discontinued Subjects 
Discontinued subjects are those who voluntarily discontinue participation, who are withdrawn for 
reasons of safety, who are lost to follow-up, so are ineligible for further participation, refer to 
section 7.8 for further details. Where possible, a full Exit Visit should be completed for all 
subjects who discontinue the study early. Where consent is withdrawn, the date and any reason 
given for discontinuation should be captured, at a minimum (see Section 7.8.2). 
Finally, if appropriate, the Investigator will also advise the subject of subsequent therapy and/or 
procedures necessary for their medical condition.  

 
Study Protocol—Device 
Prospective,  Multicenter, Post-Market Clinical  Follow-
up Study to evaluate safety and performance of the 
SUTUREFIX ULTRA and SUTUREFIX CURVED  Suture 
Anchors in shoulder and hip arthroscopic repair 
Number: 17-5010-06 
Version: 1.0, 09/MAY/2018 
Page: Page 44 of 87 
 
 
9.1.9 Subject Pregnancy 
Women of child-bearing potential are not excluded from the study: as long as adequate birth 
control methods are being used by the subject as outlined in the protocol’s exclusion criteria. 
However, if a woman becomes pregnant during the study, S&N must be contacted immediately 
once the investigator is made aware of the pregnancy and a decision will be made regarding the 
continuation in the study of the pregnant woman. Pregnancy is not an adverse event; however, 
complications related to the pregnancy may be reportable as determined on a case-by-case 
basis. Pregnancy-related information will be collected until the end of the pregnancy. 
9.2 
STUDY METHODS AND MEASUREMENTS 
All subjects 
• 
VAS for pain and satisfaction assessment* 
Hip subjects 
• 
Hip Outcome Score Activities of Daily Living (HOOS-ADL)* 
• 
Modified Harris Hip Score (HHS) * 
Shoulder subjects 
• 
ROWE Shoulder Scores* 
• 
ASES Shoulder Scores* 
• 
Constant-Murley Shoulder Scores* 
*Patient Reported Outcomes (PROs) are optional and used according to the surgeon’s preference 
9.3 
HEALTH ECONOMICS/QUALITY OF LIFE  
• 
EQ-5D-5L  
 
STATISTICAL DESIGN 
10.
The primary aim of the study is to evaluate intra-operative (6 and 12-month) safety and 
performance of the SUTUREFIX ULTRA and SUTUREFIX CURVED Suture Anchors for 
arthroscopic repair. This section of the protocol is a brief description of the analyses projected to 

 
Study Protocol—Device 
Prospective,  Multicenter, Post-Market Clinical  Follow-
up Study to evaluate safety and performance of the 
SUTUREFIX ULTRA and SUTUREFIX CURVED  Suture 
Anchors in shoulder and hip arthroscopic repair 
Number: 17-5010-06 
Version: 1.0, 09/MAY/2018 
Page: Page 45 of 87 
 
 
evaluate the aims of the study and answering the study research question. A more detailed 
Statistical Analysis Plan (SAP) will be written and finalized prior to database lock. The SAP will 
account for any changes or deviations from the projected analyses in this protocol. 
10.1 
GENERAL 
Primary and secondary endpoints will be evaluated using listings and appropriate summary 
statistics. The outcomes will be summarized for the entire sample, by device implanted 
(SUTUREFIX ULTRA and SUTUREFIX CURVED) as well as the position, i.e. the hip or the 
shoulder. The summary statistics for both primary and secondary outcomes will be reported 
together with a 95% confidence interval where necessary to assess the degree of precision in 
the estimates.  
Data tabulations and summarization will be presented to aid in the interpretation of the effects of 
clinically important variables that are disclosed. A summary of the enrolment figures by site, time 
point follow-up as well as the demographic and baseline variables, which include age, gender 
etc. will be presented. Continuous variables will be summarized using mean, median, SD, 
minimum, and maximum; categorical variables will be summarized as counts and percentages.  
All statistical tests will be exploratory in nature as the study is not powered for any statistical 
testing. Appropriate parametric and/or non-parametric analyses will be chosen for statistical 
analysis. Test of association for the table of counts will be based on the Fisher’s Exact Test 
unless otherwise inappropriate. The exploratory analysis of continuous variables will be done 
using t-test and ANOVA if appropriate. The Wilcoxon rank-sum or Kruskal-Wallis tests will be 
explored if the data is non-normal. 
For the success/failure variable, the logistic model will be considered if needed. Associated factors will be 
adjusted for in unadjusted and adjusted models, if necessary (Peacock and Kerry 2007).25 All statistical 
tests and models will be considered at 5% significance level. Adverse Events will be tabulated for the 
study duration. 

 
Study Protocol—Device 
Prospective,  Multicenter, Post-Market Clinical  Follow-
up Study to evaluate safety and performance of the 
SUTUREFIX ULTRA and SUTUREFIX CURVED  Suture 
Anchors in shoulder and hip arthroscopic repair 
Number: 17-5010-06 
Version: 1.0, 09/MAY/2018 
Page: Page 46 of 87 
 
 
All statistical analyses and calculation of confidence intervals will be performed using SAS 
software. 
10.2 
ANALYSIS POPULATIONS 
All subjects who provide informed consent are considered study participants. Study populations 
are defined as follows: 
• Full analysis set population (FAS), including all subjects who were enrolled into the 
study and attended at least one post-baseline assessment. 
• Per-Protocol Population (PP), including all subjects in the full analysis set who have 
no significant protocol deviations and met the inclusion/exclusion criteria. 
• Safety Population (SAF), including all subjects who have received IP. 
10.3 
BASELINE DATA 
Data to be summarised at baseline includes all collected demographic variable such as age, 
gender, primary diagnosis, height, weight, BMI, medical history and co-morbid conditions. The 
baseline variables will be used to describe the outcome data where necessary. Continuous 
baseline data will be summarized using frequency, means, and standard deviations, median, 
minimum and maximum. Categorical variables will be summarized using counts and 
percentages. The percentages will be calculated based on the number of non-missing values.  
 
10.4 
EFFICACY ANALYSIS 
10.4.1 Analysis of Primary Endpoint 
Clinical success rate, defined as subjects without a signs of failure and/or re-intervention at 6 
months, surgeon assessment: 

 
Study Protocol—Device 
Prospective,  Multicenter, Post-Market Clinical  Follow-
up Study to evaluate safety and performance of the 
SUTUREFIX ULTRA and SUTUREFIX CURVED  Suture 
Anchors in shoulder and hip arthroscopic repair 
Number: 17-5010-06 
Version: 1.0, 09/MAY/2018 
Page: Page 47 of 87 
 
 
• 
The frequency of the subjects without a signs of failure and/or re-intervention at 6 
months together with percentage with a 95% CI will be reported. Clinical success rate 
for the entire sample, by device implanted (SUTUREFIX ULTRA and SUTUREFIX 
CURVED) as well as the position, i.e. the hip or the shoulder will be reported.  A binary 
variable of success/failure will be used to fit a logistic model adjusting device implanted 
and position to estimate the odds ratio of success if data allows. 
10.4.2 Analysis of Secondary Endpoint(s) 
• 
Intra-operative anchor deployment success rate 
• 
Number of anchors pulled out 
• 
Use of additional anchors as a result of intra operative failure 
• 
Device-related re-intervention 
All the above variables will be categorical in nature hence frequencies together with percentages 
will be tabulated for the entire sample as well as  by device implanted (SUTUREFIX ULTRA and 
SUTUREFIX CURVED) as well as the position, i.e. the hip or the shoulder will be reported. 
All subjects 
Clinical success rate, defined as subjects without signs of failure and/or re-intervention at 12 
months; surgeon assessment 
o The frequency of the subjects without a signs of failure and/or re-intervention at 
12 months together with percentage with a 95% CI will be reported. Clinical 
success rate for the entire sample, by device implanted (SUTUREFIX ULTRA and 
SUTUREFIX CURVED) as well as the position, i.e. the hip or the shoulder will be 
reported.  A binary variable of success/failure will be used to fit a logistic model 
adjusting device implanted and position to estimate the odds ratio of success if 
data allows. 
• Subject pain assessed with a VAS at 6 months* and 12 months* 

 
Study Protocol—Device 
Prospective,  Multicenter, Post-Market Clinical  Follow-
up Study to evaluate safety and performance of the 
SUTUREFIX ULTRA and SUTUREFIX CURVED  Suture 
Anchors in shoulder and hip arthroscopic repair 
Number: 17-5010-06 
Version: 1.0, 09/MAY/2018 
Page: Page 48 of 87 
 
 
• Subject satisfaction assessed with a VAS at 6 months* and 12 months* 
• EQ-5D Questionnaire at 6 months* and 12 months* 
o The VAS and EQ-5D-5L scores at different time points and end of study for the 
entire sample, by device implanted (SUTUREFIX ULTRA and SUTUREFIX 
CURVED) as well as the position, i.e. the hip or the shoulder will be summarized 
using mean, median, SD, minimum, and maximum. A one sample t-test will be 
used to test the difference between baseline and end of study scores. A non-
parametric test will be considered if necessary. 
 
• EQ-5D-5L 
Based on the subjects responses (no problems/some or moderate problems/extreme problems) 
to each dimension (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) 
an index utility score is calculated to represent the overall EQ-5D-5L score for each subject. 
The subject responses to each dimension score and the overall EQ-5D-5L index utility scores 
and EQ VAS scores will be summarized at baseline and all post-operative visits for the entire 
sample, by device type implanted and as well as the position, i.e. the hip or the shoulder.. The 
change in EQ-5D-5L index utility score and the change in EQ VAS score between baseline and 
all post-op visits will also be summarised. 
EQ-5D-5L Utility scores and EQ VAS scores will be assessed using separate repeated 
measures ANOVA model, with the relevant score as the dependent variable for on entire sample 
with device implanted and position accounted for as levels in the model. 
Hip subjects 
• Hip Outcome Score Activities of Daily Living (HOOS-ADL) at 6 months* and 12 
months* 

 
Study Protocol—Device 
Prospective,  Multicenter, Post-Market Clinical  Follow-
up Study to evaluate safety and performance of the 
SUTUREFIX ULTRA and SUTUREFIX CURVED  Suture 
Anchors in shoulder and hip arthroscopic repair 
Number: 17-5010-06 
Version: 1.0, 09/MAY/2018 
Page: Page 49 of 87 
 
 
• Modified Harris Hip Score (HHS) at 6 months* and 12 months* 
o The HOOS and HHS scores at different time points and end of study will be will 
be summarized for the entire sample and device implanted using median, SD, 
minimum, and maximum. A one sample t-test will be used to test the difference 
between baseline and end of study scores. 
Shoulder subjects 
• ROWE Shoulder Scores at 6 months* and 12 months* 
•  ASES Shoulder Scores at 6 months* and 12 months* 
• Complete Constant-Murley Score for shoulder* at 6 months* and 12 months* 
o The ROWE and Constant-Murley Shoulder scores at different time points and end 
of study will be will be summarized for the entire sample and device implanted 
using mean, median, SD, minimum, and maximum. A one sample t-test will be 
used to test the difference between baseline and end of study scores. A non-
parametric test will be considered if necessary. 
*Patient Reported Outcomes (PROs) are optional and used according to the surgeon’s 
preference 
10.4.3 Analysis of Other Endpoint(s) 
Time to failure - intra-operative repair failure will be defined as just an event.  
• 
If adequate data is available, Kaplan Meier survival estimate for the entire sample, 
by device implanted and position will be used in this study survival analyses and a 
Cox model will also be explored adjusting for device implanted and position.   
• 
Available data will be summarized and summary statistics tabulated. 
 

 
Study Protocol—Device 
Prospective,  Multicenter, Post-Market Clinical  Follow-
up Study to evaluate safety and performance of the 
SUTUREFIX ULTRA and SUTUREFIX CURVED  Suture 
Anchors in shoulder and hip arthroscopic repair 
Number: 17-5010-06 
Version: 1.0, 09/MAY/2018 
Page: Page 50 of 87 
 
 
10.5 
SAFETY ANALYSES 
Adverse events 
• 
Adverse Events (as defined in Safety Reporting Section – All adverse events will be tabulated 
classified by seriousness and given by frequency and percentages for the entire sample 
and by device implanted (SUTUREFIX ULTRA and SUTUREFIX CURVED). 
 
10.6 
INTERIM ANALYSES 
No interim analysis is foreseen. 
 
SAMPLE SIZE JUSTIFICATION 
11.
A systematic review by Erickson et al (2015) suggests that the variation in the success rate 
among patients who have undergone any Suture Anchors for arthroscopic instability repair 
range from 71-97%. Two studies Lafosse et al (2008) and Thal et al (2007) 26 have failure rates 
of 11.4% and 6.9% within a period of 2 years from surgery, giving success rates of about 87% 
and 93% respectively suggest that building a 11% confidence interval either side of 89% will 
ensure that the estimated success rate is within literature extrapolated success rates. 
This study considers the SUTUREFIX ULTRA and SUTUREFIX CURVED Suture Anchors for arthroscopic 
repair success rate and a sample of 80 (40 per device) subjects is considered. A sample size of 40 
subjects will estimate a success rate of 89% with a 95% confidence interval (CI) [78: 100] with 55% 
probability.  
 

 
Study Protocol—Device 
Prospective,  Multicenter, Post-Market Clinical  Follow-
up Study to evaluate safety and performance of the 
SUTUREFIX ULTRA and SUTUREFIX CURVED  Suture 
Anchors in shoulder and hip arthroscopic repair 
Number: 17-5010-06 
Version: 1.0, 09/MAY/2018 
Page: Page 51 of 87 
 
 
 
ADVERSE EVENTS AND DEVICE DEFICIENCIES 
12.
12.1 
DEFINITIONS 
The categories of adverse events are shown in table 12.1-1. The definitions for each of these 
categories are given in the subsequent sections (see reference within the table). 
 
Table 12.1-1: Categories of Adverse Event 
 
NOT DEVICE- 
RELATED 
DEVICE- OR PROCEDURE-RELATED 
NON-
SERIOUS 
ADVERSE EVENT  
(AE) (SEE 12.1.1) 
ADVERSE DEVICE EFFECT  
(ADE) (SEE 12.1.2) 
SERIOUS 
SERIOUS ADVERSE 
EVENT  
(SAE)  
(SEE 12.1.3) 
SERIOUS ADVERSE DEVICE EFFECT 
(SADE) (SEE 12.1.3) 
ANTICIPATED 
UNANTICIPATED 
ANTICIPATED SERIOUS 
ADVERSE DEVICE EFFECT  
(ASADE) (SEE 12.1.4) 
UNANTICIPATED SERIOUS 
ADVERSE DEVICE EFFECT   
(USADE) (SEE 12.1.4) 
12.1.1 Adverse Event 
An Adverse Event (AE) is any untoward medical occurrence between enrollment (signed ICF 
obtained) and study discontinuation with the use of an IP, whether or not considered causally 
related to that IP.   
AE is used both to refer to AE which are non-serious non-IP or procedure-related and as an 
umbrella term referring to adverse events of all classifications.  
An AE can be any unfavorable and unintended sign (for example, an abnormal laboratory 
finding), symptom, or disease. For reporting purposes, emphasis is placed first and foremost on 
whether or not the event constitutes an untoward medical occurrence.   

 
Study Protocol—Device 
Prospective,  Multicenter, Post-Market Clinical  Follow-
up Study to evaluate safety and performance of the 
SUTUREFIX ULTRA and SUTUREFIX CURVED  Suture 
Anchors in shoulder and hip arthroscopic repair 
Number: 17-5010-06 
Version: 1.0, 09/MAY/2018 
Page: Page 52 of 87 
 
 
12.1.2 Adverse Device Effect 
An Adverse Device Effect (ADE) is an adverse event that, in the opinion of the investigator, is 
related to the IP or the procedure.  
Not Related -  An AE is considered to be not related to the use of an IP or the procedure when 
the effect is DEFINITELY UNRELATED or UNLIKELY to have any relationship to 
the use of the IP or the procedure; 
Related -  An AE is considered to be related to the use of an IP or the procedure when there is 
a POSSIBLE, PROBABLE, or DEFINITE relationship between the AE and the use of 
the IP or the procedure. 
An ADE is further categorized depending on whether the criteria in section 12.1.3 and 12.1.4 are 
met. 
12.1.3 Serious Adverse Events and Serious Adverse Device Effects  
An AE or ADE is considered a Serious Adverse Event (SAE) or Serious Adverse Device Effects 
(SADE) if, in the view of either the Investigator or the Sponsor, it: 
• 
Results in death. 
• 
Is life-threatening (NOTE: The term “life-threatening” in the definition of “serious” refers 
to an event/reaction in which the subject was at risk of death at the time of the 
event/reaction; it does not refer to an event/ reaction which hypothetically might have 
caused death if it were more severe). 
• 
Requires in subject hospitalization or results in prolongation of existing hospitalization. 
• 
Results in persistent or significant incapacity or substantial disruption of the ability to 
conduct normal life functions. 
• 
Is a congenital anomaly/birth defect. 
• 
Is a medically important event or reaction. 

 
Study Protocol—Device 
Prospective,  Multicenter, Post-Market Clinical  Follow-
up Study to evaluate safety and performance of the 
SUTUREFIX ULTRA and SUTUREFIX CURVED  Suture 
Anchors in shoulder and hip arthroscopic repair 
Number: 17-5010-06 
Version: 1.0, 09/MAY/2018 
Page: Page 53 of 87 
 
 
Medical and scientific judgment should be exercised in deciding whether other situations should 
be considered serious such as important medical events that might not be immediately life-
threatening or result in death or hospitalization but might jeopardize the subject or might require 
intervention to prevent one of the other outcomes listed in the definition above. Examples of 
such events are intensive treatment in an emergency room or at home for allergic 
bronchospasm, blood dyscrasias, or convulsions that do not result in hospitalization; or 
development of drug dependency or drug abuse. 
12.1.4 Anticipated/Unanticipated Serious Adverse Device Effect 
An Unanticipated Serious Adverse Device Effect (USADE) is a serious ADE that meets any of 
the above definitions but is also considered, by the Investigator, to be caused by or related to 
the IP, not previously identified in nature, severity or degree in the IFU 28,29,30.  
An Anticipated Serious Adverse Device Effect (ASADE) is a serious ADE that does not meet the 
criteria for a USADE 28,29,30.  
12.1.5 Severity  
The severity of every AE will be assessed by the PI or medically qualified site staff to whom the 
responsibility has been delegated and documented on the delegation of authority log. AE should 
be classified as mild, moderate, or severe, regardless of whether or not the AE are considered to 
be serious or non-serious. The classification should be based on the following definitions: 
Mild  - 
 
An event is mild if the subject is aware of, but can easily tolerate the sign or 
symptom; 
Moderate - 
An event is moderate if the sign or symptom results in discomfort significant 
enough to cause interference with the subject’s usual activities; 
Severe -   
An event is severe if the sign or symptom is incapacitating and results in the 
subject’s inability to work or engage in their usual activities. 

 
Study Protocol—Device 
Prospective,  Multicenter, Post-Market Clinical  Follow-
up Study to evaluate safety and performance of the 
SUTUREFIX ULTRA and SUTUREFIX CURVED  Suture 
Anchors in shoulder and hip arthroscopic repair 
Number: 17-5010-06 
Version: 1.0, 09/MAY/2018 
Page: Page 54 of 87 
 
 
12.1.6 Device Deficiency 
A Device Deficiency (DevD) is an inadequacy of a medical device with respect to its identity, 
quality, durability, reliability, safety or performance. DevD includes malfunctions, use errors and 
inadequate labelling.   
12.2 
REPORTING PROCEDURES 
AE of any kind and DevD will be recorded in the applicable CRF and source notes. The 
Investigator will evaluate all AE for relationship to the device and procedure, if applicable, 
seriousness, and severity. ADE, SAE, and DevD will be entered into the CRF and reported to 
the Sponsor within 24 hours of the investigator being informed about the event (Figure 12.2-1). 
For ADE and DevD, details of the product/procedure related to the event will be included and 
where applicable, pictures taken of the device. The deficient product should be retained for 
return to S&N unless it is contaminated (e.g. used dressings must not be retained). Updates to 
submitted information will be recorded in the CRF within 24 hours of the information being 
available to the investigator. 
All SAE and ADE will be reviewed by a medically qualified person appointed by the Sponsor to 
determine which, if any, meet criteria for expedited reporting to the regulatory authorities.  
The investigator will inform the IRB/IEC of adverse events according to the IRB/IEC 
requirements.  
Depending on the nature of the adverse event, S&N may request copies of the subject’s medical 
records, Imaging, Operative notes, as well as results of any relevant laboratory tests performed 
or other documentation related to the AE. If the subject was hospitalized, a copy of the 
discharge summary may be requested by S&N and should be forwarded as soon as it becomes 
available. In certain cases, S&N also may request a letter from the Investigator that summarizes 
the events related to the case. Refer to the ISF Sponsor Contact Information Sheet to report 
SAE, unanticipated ADE and SADE, anticipated SADE, and DevD.  

 
Study Protocol—Device 
Prospective,  Multicenter, Post-Market Clinical  Follow-
up Study to evaluate safety and performance of the 
SUTUREFIX ULTRA and SUTUREFIX CURVED  Suture 
Anchors in shoulder and hip arthroscopic repair 
Number: 17-5010-06 
Version: 1.0, 09/MAY/2018 
Page: Page 55 of 87 
 
 
Figure 12.2-1: Evaluation and Reporting of AE and DevD  
 
12.3 
UNBLINDING OF INVESTIGATIONAL PRODUCT 
Not Applicable. This is an open-label study. 
Site aware 
of AE
Investigator 
assesses 
seriousness 
Serious
Investigator 
assesses device 
relationship
Related 
Investigator 
assesses whether 
SADE is 
anticipated
Not Related
Serious 
Adverse 
Event (SAE)
unanticipated
Unanticpated 
Serious 
Adverse 
Device Effect 
(USADE)
Anticipated 
Serious 
Adverse 
Device 
Effect 
(ASADE)
Investigator 
assesses device 
relationship
Non-serious
Related
Adverse 
Device 
Effect (ADE)
Not Related
Adverse 
Event (AE)
Complete CRF 
and alert S&N 
within 24 
hours. 
Record details 
in subject’s 
medical 
records / 
source notes.
Device 
Deficiency 
Record information 
in patient CRF 
according to usual 
timescales.
Stop

 
Study Protocol—Device 
Prospective,  Multicenter, Post-Market Clinical  Follow-
up Study to evaluate safety and performance of the 
SUTUREFIX ULTRA and SUTUREFIX CURVED  Suture 
Anchors in shoulder and hip arthroscopic repair 
Number: 17-5010-06 
Version: 1.0, 09/MAY/2018 
Page: Page 56 of 87 
 
 
12.4 
FOLLOW-UP OF SUBJECTS WITH ADVERSE EVENTS 
For subjects who are experiencing ongoing unresolved AE at the time of their study completion 
or early discontinuation from the study, it is recommended that the Investigator schedule an 
appropriate follow-up visit in order to determine the outcome of the event.  
Any additional data must be documented and available to the Sponsor who will determine 
whether the data need to be documented within the CRF/Clinical Study Report. 
12.4.1 Ongoing Adverse Events at Study Discontinuation 
Adverse events which are related to a study procedure or S&N IP and are ongoing at end of 
subject’s participation: The event should be followed until it is either resolved or until the event 
has become chronic and is not expected to further improve based on Investigator’s review of the 
event. 
Adverse events which are not related to a study procedure or S&N IP and are ongoing at end of 
subject’s participation should be followed for 30 days after discontinuation or if the AE is 
resolved, whichever is sooner. 
At the time of data analysis (e.g. interim or final), an evaluation of ongoing events should take 
place and be listed as ongoing in the safety table. 
 
INVESTIGATOR OBLIGATIONS 
13.
The Principal Investigator (PI) will comply with the commitments outlined in the in the Statement 
of Investigator, provided by the Sponsor, and with Good Clinical Practice (GCP), and all 
applicable regulatory requirements as outlined in Appendix 21.4 of this protocol. 
In addition, the PI will ensure that the Financial Disclosure Statements will be completed by the 
PI and the Sub-Investigator upon entry into the study and as any changes that affect their 

 
Study Protocol—Device 
Prospective,  Multicenter, Post-Market Clinical  Follow-
up Study to evaluate safety and performance of the 
SUTUREFIX ULTRA and SUTUREFIX CURVED  Suture 
Anchors in shoulder and hip arthroscopic repair 
Number: 17-5010-06 
Version: 1.0, 09/MAY/2018 
Page: Page 57 of 87 
 
 
financial disclosure status occur during the course of the study and up to one year after study 
completion. 
 
SPONSOR AND MONITOR RESPONSIBILITIES 
14.
The Sponsor will designate a monitor to conduct the appropriate site visits at the appropriate 
intervals. The clinical investigation will be monitored to ensure that: the rights and wellbeing of 
the subjects are protected; the reported data are accurate, complete, and verifiable from the 
source documents; and the study is conducted in compliance with the currently approved 
protocol, with GCP regulations, and with applicable regulatory requirements. 
Detailed monitoring requirements will be documented within the Clinical Monitoring Plan for this 
study.  
14.1 
CONTRACT RESEARCH ORGANIZATION  
The Sponsor has engaged Contract Research Organization (CRO) to assist in conducting this 
study. When appropriate, the CRO is referred in study documents as “Sponsor’s agent”. 
14.2 
SITE QUALIFICATION VISIT 
A site qualification visit may be performed by the Sponsor prior to the execution of a clinical 
agreement to ensure that all Investigators have the appropriate training, staff, facilities, and 
resources to adequately conduct the study. 
14.3 
SITE INITIATION VISIT 
A site initiation visit to provide training on the specifics of the study, site obligations and 
expectations of study conduct will be performed by the Sponsor or qualified person designated 
by the Sponsor following the execution of the CTA (Clinical Trial Agreement) and documented 
IRB/IEC approval.  

 
Study Protocol—Device 
Prospective,  Multicenter, Post-Market Clinical  Follow-
up Study to evaluate safety and performance of the 
SUTUREFIX ULTRA and SUTUREFIX CURVED  Suture 
Anchors in shoulder and hip arthroscopic repair 
Number: 17-5010-06 
Version: 1.0, 09/MAY/2018 
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14.4 
SPONSOR AUDITS AND REGULATORY INSPECTION 
Quality Assurance auditors, whether an employee of the Sponsor or its designee, may evaluate 
study conduct at the study sites. These parties must have access to any and all study reports 
and source documentation, regardless of location and format.  
14.5 
CLOSE-OUT VISIT 
A study close-out visit will be performed by the Sponsor or designee to retrieve and account for 
all remaining clinical data and to resolve outstanding queries. During study close-out, the 
monitor will review investigator files to ensure required documents and records are on file, and 
review regulatory requirements regarding records retention and IRB/IEC reporting requirements.  
 
PROTOCOL AMENDMENTS 
15.
Amendments should be made only in exceptional cases once the study has started. Protocol 
amendments must be approved by the protocol signatories prior to submission to the IRB/IEC. 
Protocol amendments need to be approved by the IRB/IEC and Regulatory Authority(ies), as 
applicable prior to implementation at the site 
 
CONFIDENTIALITY OF THE STUDY 
16.
The confidentiality of this study and associated documents is governed by the terms of the 
Clinical Trial Agreement (CTA). 
 
STATEMENTS OF COMPLIANCE 
17.
This clinical study will be performed in compliance with the ethical principles of the Declaration of 
Helsinki; ISO 14155:2011 Clinical investigation of medical devices – Good Clinical Practice; ICH-
E6. 

 
Study Protocol—Device 
Prospective,  Multicenter, Post-Market Clinical  Follow-
up Study to evaluate safety and performance of the 
SUTUREFIX ULTRA and SUTUREFIX CURVED  Suture 
Anchors in shoulder and hip arthroscopic repair 
Number: 17-5010-06 
Version: 1.0, 09/MAY/2018 
Page: Page 59 of 87 
 
 
This clinical study will not commence until the required approval/favorable opinion from the 
IRB/IEC or regulatory authority has been obtained. Any additional requirements imposed by the 
IRB/IEC or regulatory authority will be followed.  
Public/Products Liability Insurance has been purchased by Smith & Nephew plc. Worldwide and 
incorporates coverage for personal injury in respect of clinical studies. The Sponsor agrees to 
operate in good faith and in accordance with ABHI (Association of British Healthcare Industries) 
guidelines regarding compensation for injury arising in the course of clinical studies. 
 
END OF STUDY 
18.
The end of the study is defined by the last visit of the last subject undergoing treatment in the 
study.  
 
PUBLICATION POLICY 
19.
19.1 
PUBLICATION OF STUDY DATA 
The preparation and submission for publication of manuscripts containing the study results shall 
be in accordance with a process determined by the Clinical Trial Agreements between the study 
Sponsor and participating institutions. The publication or presentation of any study results shall 
comply with all applicable privacy laws, including, but not limited to the Health Insurance 
Portability and Accountability Act of 1996. 
19.2 
DATA SHARING 
Smith & Nephew is committed to upholding the highest ethical and legal standards involved in 
conducting clinical trials. Smith & Nephew therefore supports the data sharing requirements of 
The International Committee of Medical Journal Editors (ICMJE) published on the 6th June 
2017. In accordance, Smith & Nephew will consider requests to share individual (deidentified) 
participant data that underlie the results of any interventional clinical trial, as presented from the 
1st July 2018 within an ICMJE associated journal. Requests made by researchers who provide a 

 
Study Protocol—Device 
Prospective,  Multicenter, Post-Market Clinical  Follow-
up Study to evaluate safety and performance of the 
SUTUREFIX ULTRA and SUTUREFIX CURVED  Suture 
Anchors in shoulder and hip arthroscopic repair 
Number: 17-5010-06 
Version: 1.0, 09/MAY/2018 
Page: Page 60 of 87 
 
 
methodologically sound proposal will be considered. Requests may include data that underlie 
results presented in text, tables, figures and appendices, together with data dictionaries. 
Availability of these data will begin 9 months and end 36 months after article publication. Data 
supplied may only be used by the researcher(s) named in the approved research proposal for 
the purposes of achieving the aims of the analyses specified therein. All proposals should be 
directed to datasharing.gcs@smith-nephew.com. To gain access, data requestors will need to 
sign a data access agreement. 
 
REFERENCES 
20.
1. 
Demehri S, Hafezi-Nejad N, Fishman EK. Advanced imaging of glenohumeral instability: the role 
of MRI and MDCT in providing what clinicians need to know. Emergency radiology. 2017;24(1):95-
103. 
2. 
Erickson J, Lavery K, Monica J, Gatt C, Dhawan A. Surgical treatment of symptomatic superior 
labrum anterior-posterior tears in patients older than 40 years: a systematic review. Am J Sports 
Med. 2015;43(5):1274-1282. 
3. 
Werner BC, Brockmeier SF, Miller MD. Etiology, Diagnosis, and Management of Failed SLAP 
Repair. The Journal of the American Academy of Orthopaedic Surgeons. 2014;22(9):554-565. 
4. 
McCormick F, Bhatia S, Chalmers P, Gupta A, Verma N, Romeo AA. The management of type II 
superior labral anterior to posterior injuries. The Orthopedic clinics of North America. 
2014;45(1):121-128. 
5. 
Zlatkin MB, Sanders TG. Magnetic resonance imaging of the glenoid labrum. Radiologic clinics of 
North America. 2013;51(2):279-297. 
6. 
Rossy W, Sanchez G, Sanchez A, Provencher MT. Superior Labral Anterior-Posterior (SLAP) 
Tears in the Military. Sports health. 2016;8(6):503-506. 
7. 
Tayrose GA, Karas SG, Bosco J. Biceps Tenodesis for Type II SLAP Tears. Bulletin of the Hospital 
for Joint Disease (2013). 2015;73(2):116-121. 
8. 
Griffin JW, Leroux TS, Romeo AA. Management of Proximal Biceps Pathology in Overhead 
Athletes: What Is the Role of Biceps Tenodesis? American journal of orthopedics (Belle Mead, N.J.). 
2017;46(1):E71-e78. 
9. 
Vianello R, Pannone A, Conca M, Corezzola R. Return to Sport After Shoulder Arthroscopy. In: 
Volpi P, ed. Arthroscopy and Sport Injuries: Applications in High-level Athletes. Cham: Springer 
International Publishing; 2016:175-184. 
10. 
Smith MV, Calfee RP, Baumgarten KM, Brophy RH, Wright RW. Upper Extremity-Specific 
Measures of Disability and Outcomes in Orthopaedic Surgery. The Journal of Bone and Joint 
Surgery. American volume. 2012;94(3):277-285. 

 
Study Protocol—Device 
Prospective,  Multicenter, Post-Market Clinical  Follow-
up Study to evaluate safety and performance of the 
SUTUREFIX ULTRA and SUTUREFIX CURVED  Suture 
Anchors in shoulder and hip arthroscopic repair 
Number: 17-5010-06 
Version: 1.0, 09/MAY/2018 
Page: Page 61 of 87 
 
 
11. 
Mook WR, Briggs KK, Philippon MJ. Evidence and Approach for Management of Labral 
Deficiency: The Role for Labral Reconstruction. Sports medicine and arthroscopy review. 
2015;23(4):205-212. 
12. 
Ayeni OR, Adamich J, Farrokhyar F, et al. Surgical management of labral tears during 
femoroacetabular impingement surgery: a systematic review. Knee surgery, sports traumatology, 
arthroscopy : official journal of the ESSKA. 2014;22(4):756-762. 
13. 
Fayad TE, Khan MA, Haddad FS. Femoroacetabular impingement: an arthroscopic solution. The 
bone & joint journal. 2013;95-b(11 Suppl A):26-30. 
14. 
Kollmorgen R, Mather R. Current Concepts in Labral Repair and Refixation: Anatomical Approach 
to Labral Management. American journal of orthopedics (Belle Mead, N.J.). 2017;46(1):42-48. 
15. 
Skendzel JG, Philippon MJ. Management of labral tears of the hip in young patients. The 
Orthopedic clinics of North America. 2013;44(4):477-487. 
16. 
Wolff AB, Grossman J. Management of the Acetabular Labrum. Clinics in sports medicine. 
2016;35(3):345-360. 
17. 
El Bitar YF, Lindner D, Jackson TJ, Domb BG. Joint-preserving surgical options for management 
of chondral injuries of the hip. The Journal of the American Academy of Orthopaedic Surgeons. 
2014;22(1):46-56. 
18. 
Khan M, Bedi A, Fu F, Karlsson J, Ayeni OR, Bhandari M. New perspectives on 
femoroacetabular impingement syndrome. Nature reviews. Rheumatology. 2016;12(5):303-310. 
19. 
Salata MJ, Vasileff WK. Management of Labral and Chondral Disease in Hip Preservation 
Surgery. Sports medicine and arthroscopy review. 2015;23(4):200-204. 
20. 
Kivlan BR, Nho SJ, Christoforetti JJ, et al. Multicenter Outcomes After Hip Arthroscopy: 
Epidemiology (MASH Study Group). What Are We Seeing in the Office, and Who Are We Choosing 
to Treat? American journal of orthopedics (Belle Mead, N.J.). 2017;46(1):35-41. 
21. 
Agrawal V, Pietrzak WS. Triple labrum tears25. repaired with the JuggerKnot soft anchor: 
Technique and results. Int J Shoulder Surg. 2015;9(3):81-89. 
22. 
Boileau P, Gendre P, Baba M, et al. A guided surgical approach and novel fixation method for 
arthroscopic Latarjet. Journal of Shoulder and Elbow Surgery. 2015. 
23. 
Matsuda DK, Gupta N, Burchette RJ, Sehgal B. Arthroscopic surgery for global versus focal 
pincer femoroacetabular impingement: are the outcomes different? Journal of Hip Preservation 
Surgery. 2015:hnv010. 
24.        Agrawall V, Pietrzak WS. Triple labrum tears repaire with the JunggerKnot soft anchor: T 
Technique and results. Int J Shoulder Surg. Jul-Sep 2015;9(3):81-89 
25.  
Peacock JL, Kerry S. Presenting medical statistics from proposal to publication: a step-by-step 
guide.  Oxford  University Press; 2007.  
26. 
Lafosse, L., Brzoska, R., Toussaint, B. and Gobezie, R., 2008. The outcome and structural 
 
integrity of arthroscopic rotator cuff repair with use of the double-row suture anchor technique. J 
 
Bone Joint Surg Am, (Supplement 2 Part 2), pp.275-286. 

 
Study Protocol—Device 
Prospective,  Multicenter, Post-Market Clinical  Follow-
up Study to evaluate safety and performance of the 
SUTUREFIX ULTRA and SUTUREFIX CURVED  Suture 
Anchors in shoulder and hip arthroscopic repair 
Number: 17-5010-06 
Version: 1.0, 09/MAY/2018 
Page: Page 62 of 87 
 
 
27.  
Salaffi F, Sarzi-Puttini P, Atzeni F. Best Pract Res Clin Rheumatol. 2015 Feb;29(1):164-86. doi: 
 
10.1016/j.berh.2015.04.023. Epub 2015 Jun 19. Review.  
28.  
ISO 14155:2011  
29  
CFR 812  
30. 
ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited 
 
Reporting 
 
 
 
 
 

 
Study Protocol—Device 
Prospective,  Multicenter, Post-Market Clinical  Follow-
up Study to evaluate safety and performance of the 
SUTUREFIX ULTRA and SUTUREFIX CURVED  Suture 
Anchors in shoulder and hip arthroscopic repair 
Number: 17-5010-06 
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APPENDICES 
21.
21.1 
INSTRUCTIONS FOR USE SUTUREFIX ULTRA AND SUTUREFIX CURVED 

 
Study Protocol—Device 
Prospective,  Multicenter, Post-Market Clinical  Follow-
up Study to evaluate safety and performance of the 
SUTUREFIX ULTRA and SUTUREFIX CURVED  Suture 
Anchors in shoulder and hip arthroscopic repair 
Number: 17-5010-06 
Version: 1.0, 09/MAY/2018 
Page: Page 64 of 87 
 
 
 

 
Study Protocol—Device 
Prospective,  Multicenter, Post-Market Clinical  Follow-
up Study to evaluate safety and performance of the 
SUTUREFIX ULTRA and SUTUREFIX CURVED  Suture 
Anchors in shoulder and hip arthroscopic repair 
Number: 17-5010-06 
Version: 1.0, 09/MAY/2018 
Page: Page 65 of 87 
 
 
 

 
Study Protocol—Device 
Prospective,  Multicenter, Post-Market Clinical  Follow-
up Study to evaluate safety and performance of the 
SUTUREFIX ULTRA and SUTUREFIX CURVED  Suture 
Anchors in shoulder and hip arthroscopic repair 
Number: 17-5010-06 
Version: 1.0, 09/MAY/2018 
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21.2 
PROTOCOL AMENDMENT 
Not applicable, this protocol has not been amended. 

 
Study Protocol—Device 
Prospective,  Multicenter, Post-Market Clinical  Follow-
up Study to evaluate safety and performance of the 
SUTUREFIX ULTRA and SUTUREFIX CURVED  Suture 
Anchors in shoulder and hip arthroscopic repair 
Number: 17-5010-06 
Version: 1.0, 09/MAY/2018 
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21.3 
 QUALITY OF LIFE MEASURES EQ-5D-5L 
 
 

 
Study Protocol—Device 
Prospective,  Multicenter, Post-Market Clinical  Follow-
up Study to evaluate safety and performance of the 
SUTUREFIX ULTRA and SUTUREFIX CURVED  Suture 
Anchors in shoulder and hip arthroscopic repair 
Number: 17-5010-06 
Version: 1.0, 09/MAY/2018 
Page: Page 68 of 87 
 
 
 
 

 
Study Protocol—Device 
Prospective,  Multicenter, Post-Market Clinical  Follow-
up Study to evaluate safety and performance of the 
SUTUREFIX ULTRA and SUTUREFIX CURVED  Suture 
Anchors in shoulder and hip arthroscopic repair 
Number: 17-5010-06 
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21.4 
ADDITIONAL ASSESSMENTS  
 
 

 
Study Protocol—Device 
Prospective,  Multicenter, Post-Market Clinical  Follow-
up Study to evaluate safety and performance of the 
SUTUREFIX ULTRA and SUTUREFIX CURVED  Suture 
Anchors in shoulder and hip arthroscopic repair 
Number: 17-5010-06 
Version: 1.0, 09/MAY/2018 
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Study Protocol—Device 
Prospective,  Multicenter, Post-Market Clinical  Follow-
up Study to evaluate safety and performance of the 
SUTUREFIX ULTRA and SUTUREFIX CURVED  Suture 
Anchors in shoulder and hip arthroscopic repair 
Number: 17-5010-06 
Version: 1.0, 09/MAY/2018 
Page: Page 71 of 87 
 
 
 

 
Study Protocol—Device 
Prospective,  Multicenter, Post-Market Clinical  Follow-
up Study to evaluate safety and performance of the 
SUTUREFIX ULTRA and SUTUREFIX CURVED  Suture 
Anchors in shoulder and hip arthroscopic repair 
Number: 17-5010-06 
Version: 1.0, 09/MAY/2018 
Page: Page 72 of 87 
 
 
 

 
Study Protocol—Device 
Prospective,  Multicenter, Post-Market Clinical  Follow-
up Study to evaluate safety and performance of the 
SUTUREFIX ULTRA and SUTUREFIX CURVED  Suture 
Anchors in shoulder and hip arthroscopic repair 
Number: 17-5010-06 
Version: 1.0, 09/MAY/2018 
Page: Page 73 of 87 
 
 
 

 
Study Protocol—Device 
Prospective,  Multicenter, Post-Market Clinical  Follow-
up Study to evaluate safety and performance of the 
SUTUREFIX ULTRA and SUTUREFIX CURVED  Suture 
Anchors in shoulder and hip arthroscopic repair 
Number: 17-5010-06 
Version: 1.0, 09/MAY/2018 
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Study Protocol—Device 
Prospective,  Multicenter, Post-Market Clinical  Follow-
up Study to evaluate safety and performance of the 
SUTUREFIX ULTRA and SUTUREFIX CURVED  Suture 
Anchors in shoulder and hip arthroscopic repair 
Number: 17-5010-06 
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Study Protocol—Device 
Prospective,  Multicenter, Post-Market Clinical  Follow-
up Study to evaluate safety and performance of the 
SUTUREFIX ULTRA and SUTUREFIX CURVED  Suture 
Anchors in shoulder and hip arthroscopic repair 
Number: 17-5010-06 
Version: 1.0, 09/MAY/2018 
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Study Protocol—Device 
Prospective,  Multicenter, Post-Market Clinical  Follow-
up Study to evaluate safety and performance of the 
SUTUREFIX ULTRA and SUTUREFIX CURVED  Suture 
Anchors in shoulder and hip arthroscopic repair 
Number: 17-5010-06 
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Study Protocol—Device 
Prospective,  Multicenter, Post-Market Clinical  Follow-
up Study to evaluate safety and performance of the 
SUTUREFIX ULTRA and SUTUREFIX CURVED  Suture 
Anchors in shoulder and hip arthroscopic repair 
Number: 17-5010-06 
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Study Protocol—Device 
Prospective,  Multicenter, Post-Market Clinical  Follow-
up Study to evaluate safety and performance of the 
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Anchors in shoulder and hip arthroscopic repair 
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21.5 
PRINCIPAL INVESTIGATOR OBLIGATIONS (ISO 14155:2011) 
1. General:  
a. 
The role of the PI is to implement and manage the day-to-day conduct of the clinical 
investigation as well as ensure data integrity and the rights, safety, and well-being of 
the subjects involved in the clinical investigation.  
2. Qualification of the PI. The PI shall: 
a. 
be qualified by education, training, and experience to assume responsibility for the 
proper conduct of the clinical investigation in accordance with this International 
Standard; evidence of such qualifications of the PI and key members of the 
investigation site team shall be provided to the Sponsor through up-to-date Curriculum 
Vitae (CV) or other relevant documentation, 
b. 
be experienced in the field of application and trained in the use of the investigational 
device under consideration, 
c. 
disclose potential conflicts of interest, including financial, that interfere with the conduct 
of the clinical investigation or interpretation of results, and 
d. 
be knowledgeable with the method of obtaining informed consent. 
3. Qualification of investigation site. The PI shall be able to demonstrate that the proposed 
investigation site: 
a. 
has the required number of eligible subjects needed within the agreed recruitment 
period, and 
b. 
has one or more qualified investigators, a qualified investigation site team and adequate 
facilities for the foreseen duration of the clinical investigation. 
4. Communication with the IEC. The PI shall:  
a. 
provide the Sponsor with copies of any clinical-investigation-related communications 
between the PI and the IEC, 
b. 
comply with the requirements described in 4.5 of ISO 14155:2011: 
i. 
Submit to the IEC the following information, any amendments and any additional 
documentation required by the IEC: the Protocol; IB or equivalent; informed 

 
Study Protocol—Device 
Prospective,  Multicenter, Post-Market Clinical  Follow-
up Study to evaluate safety and performance of the 
SUTUREFIX ULTRA and SUTUREFIX CURVED  Suture 
Anchors in shoulder and hip arthroscopic repair 
Number: 17-5010-06 
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consent form and any other written information provided to subjects; procedures 
for recruiting subjects and advertising materials, if any; a copy of the CV of the 
PI(s) for with the IEC has oversight. 
ii. 
Provide documentation of the IECs approval/favorable opinion, identifying the 
documents and amendments on which the opinion was based, to the Sponsor, 
prior to commencing the clinical investigation.  
iii. 
Submit the following to the IEC if required by national regulations, the protocol or 
IEC, whichever is more stringent: 
1. 
SAEs 
2. 
Requests for deviations, and reports of deviations, if the deviation affects 
subject’s rights, safety, and well-being, or the scientific integrity of the clinical 
investigation. Document and report to the Sponsor and IEC a report of 
deviations made to protect the rights, safety, and well-being of human 
subjects under emergency circumstances.  
3. 
Progress reports, including safety summary and deviations 
4. 
Amendments to any documents already approved by the IEC.  
5. 
If applicable, notifications of suspension or premature termination 
6. 
If applicable, justification and request for resuming the clinical investigation 
after suspension.  
7. 
Clinical investigation report or summary. 
iv. 
As a minimum, during the clinical investigation, the following information shall be 
obtained in writing from the IEC prior to implementation: 
1. 
Approval/favorable opinion of amendments 
2. 
Approval of the request for deviations that can affect the subject’s rights, 
safety, and well-being or scientific integrity of the clinical investigation 
3. 
Approval for resumption of a suspended clinical investigation if applicable.  
c. 
obtain the written and dated approval/favorable opinion of the IEC for the clinical 
investigation before recruiting subjects and implementing all subsequent amendments, 
if required, 

 
Study Protocol—Device 
Prospective,  Multicenter, Post-Market Clinical  Follow-
up Study to evaluate safety and performance of the 
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d. 
promptly report any deviations from the protocol that affect the rights, safety or well-
being of the subject or the scientific integrity of the clinical investigation, including those 
which occur under emergency circumstances, if required by the IEC, protocol or 
national regulations. In particular circumstances, the communication with the IEC can 
be performed by the Sponsor, partly or in full, in which case the Sponsor shall keep the 
Principal Investigator informed. 
5. Informed consent process. The PI shall: 
a. 
General: 
i. 
Informed consent shall be obtained in writing from the subject and the process 
shall be documented before any procedure specific to the clinical investigation is 
applied to the subject; except when special circumstances for emergency 
treatments apply (see below) 
ii. 
The informed consent form consists of an information form and informed consent 
signature form. These two forms can either be combined in one document or 
separated into two documents 
b. 
Process of obtaining informed consent. The general process for obtaining informed 
consent shall be documented in the protocol and shall comply with the following. These 
requirements also apply with respect to informed consent obtained from a subject’s 
legally authorized representative:  
i. 
Ensure that the PI or his/her authorized designee conducts the informed consent 
process 
ii. 
Include all aspects of the clinical investigation that are relevant to the subject’s 
decision to participate throughout the clinical investigation 
iii. 
Avoid any coercion or undue improper influence on, or inducement of, the subject 
to participate 
iv. 
Not waive or appear to waive the subject’s legal rights 
v. 
Use native non-technical language that is understandable to the subject 
vi. 
Provide ample time for the subject to read and understand the informed consent 
form and to consider participation in the clinical investigation 

 
Study Protocol—Device 
Prospective,  Multicenter, Post-Market Clinical  Follow-
up Study to evaluate safety and performance of the 
SUTUREFIX ULTRA and SUTUREFIX CURVED  Suture 
Anchors in shoulder and hip arthroscopic repair 
Number: 17-5010-06 
Version: 1.0, 09/MAY/2018 
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vii. 
Include personally dated signatures and the PI or an authorized designee 
responsible for conducting the informed consent process 
viii. 
Show how informed consent will be obtained in special circumstances (see below) 
where the subject is unable to provide him or herself, and  
ix. 
Ensure important new information is provided to new and existing subjects 
throughout the clinical investigation.  
c. 
Special circumstances for informed consent (the following provisions are subject to 
national regulations): 
i. 
Subject needing legally authorized representatives:  informed consent may be 
given by the legally authorized representative only if a subject is unable to make 
the decision to participate in a clinical investigation (e.g. infant, child, or juvenile, 
seriously ill or unconscious subject, mentally ill person, mentally handicapped 
person). In such cases, the subject shall also be informed about the clinical 
investigation within his/her ability to understand.  
ii. 
Subject unable to read or write: informed consent shall be obtained through a 
supervised oral process if a subject or legally authorized representative is unable 
to read or write. An independent witness shall be present throughout the process. 
The written informed consent form and any other information shall be read aloud 
and explained to the prospective subject or his/her legally authorized 
representative and, whenever possible, either shall sign and personally date the 
informed consent form. The witness also signs and personally dates the informed 
consent for attesting that the information was accurately explained and that the 
informed consent was freely given.  
iii. 
Emergency treatments:  
1. 
For clinical investigations involving emergency treatments, when prior 
informed consent of the subject is not possible because of the subject’s 
medical condition, the informed consent of the subject’s legally authorized 
representative, if present, shall be requested.  

 
Study Protocol—Device 
Prospective,  Multicenter, Post-Market Clinical  Follow-
up Study to evaluate safety and performance of the 
SUTUREFIX ULTRA and SUTUREFIX CURVED  Suture 
Anchors in shoulder and hip arthroscopic repair 
Number: 17-5010-06 
Version: 1.0, 09/MAY/2018 
Page: Page 83 of 87 
 
 
2. 
When it is not possible to obtain prior informed consent from the subject, and 
the subject’s legally authorized representative, is not available, the subject 
may still be enrolled if a specific process has been described in the protocol.  
3. 
Arrangements shall be made to inform the subject or legally authorized 
representative, as soon as possible, about the subject’s inclusion in the 
clinical investigation and about all aspects of the clinical investigation.  
4. 
The subject shall be asked to provide informed consent for continued 
participation as soon as his/her medical condition allows.  
d. 
The Principal Investigator may not enroll a subject without obtaining informed consent 
of the subject or his/her legally authorized representative only when the following 
conditions are fulfilled: the prospective subject fulfils the emergency conditions and is 
obviously in a life-threatening situation; no sufficient clinical benefits are anticipated 
from the currently available treatment; there is a fair possibility that the life-threatening 
risk to the prospective subject can be avoided if the investigational device is used; 
anticipated risks are outweighed by the potential benefits of applying the investigational 
device ; the legally authorized representative cannot be promptly reached and informed.  
e. 
Information provided to the subject. All information pertinent to the clinical investigation, 
including at least the following, shall be provided in writing and in native, non-technical 
language that is understandable to the subject (or the subject’s legally authorized 
representative): 
i. 
Description and purpose 
ii. 
Potential benefits 
iii. 
Risks and inconveniences or the subject and, when applicable, for any embryo, 
foetus or nursing infant 
iv. 
Alternative procedures 
v. 
Confidentiality 
vi. 
Compensation 
vii. 
Anticipated expenses, if any, to be borne by the subject for participating in the 
clinical investigation 

 
Study Protocol—Device 
Prospective,  Multicenter, Post-Market Clinical  Follow-
up Study to evaluate safety and performance of the 
SUTUREFIX ULTRA and SUTUREFIX CURVED  Suture 
Anchors in shoulder and hip arthroscopic repair 
Number: 17-5010-06 
Version: 1.0, 09/MAY/2018 
Page: Page 84 of 87 
 
 
viii. 
Information on the role of Sponsor’s representative in the clinical investigation 
ix. 
Contact persons 
x. 
Statement declaring that new findings or the reasons for any amendment to the 
protocol that affect the subject’s continued participation shall be made available to 
the subject.  
xi. 
Statement indicating that, upon the subject’s approval, the subject’s personal 
physician will be informed of the subject’s participation in the clinical investigation 
xii. 
Termination procedures 
f. 
Informed consent signature shall contain the following:  
i. 
The voluntary agreement to participate in the clinical investigation and follow the 
investigator’s instructions 
ii. 
A statement declaring that refusal of participation incurs no penalty for the subject 
iii. 
A statement declaring that discontinuation at any time incurs no penalty for the 
subject 
iv. 
A statement with regard to the possible consequences of withdrawal 
v. 
An acknowledgement of the information provided and confirmation that all the 
subject’s questions were answered 
vi. 
A statement confirming that the subject or his/her legally authorized 
representative agrees to the use of the subject’s relevant personal data for the 
purpose of the clinical investigation 
vii. 
A statement confirming that the subject or his/her legally authorized 
representative agrees that Sponsor’s representatives, regulatory authorities and 
IEC representatives will be granted direct access to the subject’s medical records.  
g. 
New information: if new information becomes available that can significantly affect a 
subject’s future health and medical care, that information shall be provided to the 
subject(s) affected in written form. If relevant, all affected subjects shall be asked to 
confirm their continuing consent in writing.  
h. 
ensure compliance with the applicable regulatory requirements and ethical principles for 
the process of obtaining informed consent, and 

 
Study Protocol—Device 
Prospective,  Multicenter, Post-Market Clinical  Follow-
up Study to evaluate safety and performance of the 
SUTUREFIX ULTRA and SUTUREFIX CURVED  Suture 
Anchors in shoulder and hip arthroscopic repair 
Number: 17-5010-06 
Version: 1.0, 09/MAY/2018 
Page: Page 85 of 87 
 
 
i. 
ensure and document appropriate training if an authorized designee is appointed to 
conduct the informed consent process. 
6. Compliance with the protocol. The Principal Investigator shall: 
a. 
indicate his/her acceptance of the protocol in writing, 
b. 
conduct the clinical investigation in compliance with the protocol, 
c. 
create and maintain source documents throughout the clinical investigation and make 
them available as requested during monitoring visits or audits, 
d. 
ensure that the investigational device is used solely by authorized users as specified in 
6.2, and in accordance with the protocol and instructions for use, 
e. 
propose to the Sponsor any appropriate modification(s) of the protocol or investigational 
device or of the use of the investigational device, 
f. 
refrain from implementing any modifications to the protocol without agreement from the 
Sponsor, IEC and regulatory authorities, if required, 
g. 
document and explain any deviation from the approved protocol that occurred during 
the course of the clinical investigation, 
h. 
ensure that an adequate investigation site team and facilities exist and are maintained 
and documented during the clinical investigation, 
i. 
ensure that maintenance and calibration of the equipment relevant for the assessment 
of the clinical investigation is appropriately performed and documented, where 
applicable, 
j. 
ensure the accuracy, completeness, legibility and timeliness of the data reported to the 
Sponsor in the CRF and in all required reports, 
k. 
maintain the device accountability records, 
l. 
allow and support the Sponsor to perform monitoring and auditing activities, 
m. be accessible to the monitor and respond to questions during monitoring visits, 
n. 
allow and support regulatory authorities and the IEC when performing auditing 
activities, 
o. 
ensure that all clinical-investigation-related records are retained as required taking 
measures to prevent accidental or premature destruction, and 

 
Study Protocol—Device 
Prospective,  Multicenter, Post-Market Clinical  Follow-
up Study to evaluate safety and performance of the 
SUTUREFIX ULTRA and SUTUREFIX CURVED  Suture 
Anchors in shoulder and hip arthroscopic repair 
Number: 17-5010-06 
Version: 1.0, 09/MAY/2018 
Page: Page 86 of 87 
 
 
p. 
review and sign the clinical investigation report, as applicable. 
7. Medical care of subjects. The Principal Investigator shall 
a. 
provide adequate medical care to a subject during and after a subject's participation in 
a clinical investigation in the case of adverse events,  
b. 
inform the subject of the nature and possible cause of any adverse events experienced, 
c. 
provide the subject with the necessary instructions on proper use, handling, storage, 
and return of the investigational device, when it is used or operated by the subject, 
d. 
inform the subject of any new significant findings occurring during the clinical 
investigation, including the need for additional medical care that may be required, 
e. 
provide the subject with well-defined procedures for possible emergency situations 
related to the clinical investigation, and make the necessary arrangements for 
emergency treatment, including decoding procedures for blinded/masked clinical 
investigations, as needed, 
f. 
ensure that clinical records are clearly marked to indicate that the subject is enrolled in 
a particular clinical investigation, 
g. 
if appropriate, subjects enrolled in the clinical investigation shall be provided with some 
means of showing their participation in the clinical investigation, together with 
identification and compliance information for concomitant treatment measures (contact 
address and telephone numbers shall be provided), 
h. 
inform, with the subject's approval or when required by national regulations, the 
subject's personal physician about the subject's participation in the clinical investigation, 
and  
i. 
make all reasonable efforts to ascertain the reason(s) for a subject's premature 
withdrawal from the clinical investigation while fully respecting the subject's rights. 
8. Safety reporting. The Principal Investigator shall: 
a. 
record every adverse event and observed device deficiency, together with an 
assessment, 

 
Study Protocol—Device 
Prospective,  Multicenter, Post-Market Clinical  Follow-
up Study to evaluate safety and performance of the 
SUTUREFIX ULTRA and SUTUREFIX CURVED  Suture 
Anchors in shoulder and hip arthroscopic repair 
Number: 17-5010-06 
Version: 1.0, 09/MAY/2018 
Page: Page 87 of 87 
 
 
b. 
report to the Sponsor, without unjustified delay, all serious adverse events and device 
deficiencies that could have led to a serious adverse device effect; this information shall 
be promptly followed by detailed written reports, as specified in the protocol, 
c. 
c) report to the IEC serious adverse events and device deficiencies that could have led 
to a serious adverse device effect, if required by the national regulations or protocol or 
by the IEC, 
d. 
report to regulatory authorities serious adverse events and device deficiencies that 
could have led to a serious adverse device effect, as required by the national 
regulations, and 
e. 
supply the Sponsor, upon Sponsor's request, with any additional information related to 
the safety reporting of a particular event.