Safety and Performance of Q-Fix™ All-Suture Anchor System
Conditions: Bankart Lesion, Acetabular Labrum Tear, SLAP Lesion, Acromioclavicular Sprain, Capsular Shift/Capsulolabral Reconstruction, Deltoid Repair, Rotator Cuff Repair, Bicep Tendinitis, Extra-capsular Repair, Medial Collateral Ligament, Lateal Collateral Ligament, Posterior Oblique Ligament, IBT, Vastus Medialis, Obliquus Advancement, Joint Capsule Closure
Sponsor: Smith & Nephew, Inc.

Study Protocol
Device
Safety and Performance of Q-
-Suture Anchor 
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CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
SOP-059 Clinical Protocols 
 
 
 
Safety and Performance of Q-
-Suture Anchor System 
 
Protocol Number: 
17-5010-11 
Protocol Version and Date: 
Version 2.0 05SEP2019 
Study Product Name: 
Q-
-Suture Anchor System 
Sponsor: 
Smith & Nephew, Inc.  
 
 
 

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Device
Safety and Performance of Q-
-Suture Anchor 
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CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
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 SIGNATURES 
1.1 
PROTOCOL SIGNATURE PAGE 
This page will be returned to Smith & Nephew Inc. and a copy retained at the investigational site. 
Safety and Performance of Q-
All-
version 2.0, dated 05SEP2019, and agree to abide by all provisions set forth herein. 
I agree to comply with 
tions stipulated in Section 15.0 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, Inc.   
Role 
Name 
Signature 
Date Signed
(DD-MMM-YYYY) 
Principal Investigator 
 
 
 
 
 
 
 
 
 
 
 
 
 

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CONFIDENTIAL AND PROPRIETARY 
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intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
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1.2 
SPONSOR APPROVAL  
Job title
DocuSign Stamp
Shirley Mak-Parisi, Regional 
Operations Manager 
 
 
Stephan Mangin,  Clinical 
Strategy Lead 
 
 
 
Alan Rossington, Head of 
Global Biostatistics 
 
 
 
 
 
 
Luca Orlandini, Medical Affairs 
Representative 
 
 
 
 
 

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-Suture Anchor 
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CONFIDENTIAL AND PROPRIETARY 
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intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
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 SYNOPSIS 
Title of Study:
Safety and Performance of Q-
-Suture Anchor System
Study Design:
A retrospective, multi-center, case series
Study Type:
Observational,  post-market,  clinical follow-up study
Study Product:
Q-
-Suture Anchor System
Model Specification 
72290123 
1.8MM MINI 
25-1800 
1.8MM 
25-2800 
2.8MM 
Study Purpose:
Post-market clinical follow-up needed to address existing clinical data 
and gaps on the existing Q-Fix   device and meet existing 
MDD/MEDDEV requirements 
Primary Objective:
To assess the safety and performance data of the Q-
-Suture 
Anchor System. 
Statistical Rationale: 
The study sample was decided based on the feasibility of recruitment, 
enrollment and follow-up considerations. Based on the results of a 
1.8% failure rate for the Q-Fix  Suture Anchor in the study conducted 
by Byrd et al25, it is reasonable to estimate a success rate of 95% for 
the Q-Fix  Suture Anchors in this study. The proportions of clinical 
success as defined in this study will be displayed with a confidence 
interval.  
Sample Size: 
A total minimum sample size of 90 subjects is proposed with a 
maximum of 450 subjects (depending on market share) for approved 
joint indications. Please see table below for enrollment distribution 
 

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-Suture Anchor 
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CONFIDENTIAL AND PROPRIETARY 
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intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
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Joint indication
Number of Subjects
Hip
Minimum 30
Maximum 150 
Shoulder
Minimum 30
Maximum 150 
Knee
Minimum 30
Maximum 150 
 
Number of Study Sites:
Approximately 3 sites for each joint indication: up to 9 sites total
Targeted Global Regions:
United States (US)
Inclusion Criteria:
1. Subject has undergone arthroscopic or open soft tissue repair 
with Q-Fix  All-Suture Anchor System 
2. Subject was   13 of age at time of surgery 
Exclusion Criteria:
1. Subject is   6 months post-operative
2. Subject is entered in another investigational drug, biologic, or 
device study or has been treated with an investigational 
product within 12 months post-operative. 
Study Duration: 
The expected timeline for the study is a total of approximately 2.5 
years: 
 
6 months for site initiation 
 
16 months for subject enrollment 
 
2 months for follow-up 
 
6 months to analyze the data and prepare the final study 
report. 

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CONFIDENTIAL AND PROPRIETARY 
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intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
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Primary endpoint:
 
Clinical success rate, defined as subjects without  re-
intervention at 6 months post-operative, as assessed by the 
surgeon 
Secondary endpoints:
 
Clinical success rate, defined as subjects without re-
intervention at 12 months post-operative, as assessed by the 
surgeon 
 
Visual Analog Scale (VAS) - pain 
 
Range of Motion (ROM) 
 
Clinical success rate in adolescents and young adults, defined 
as subjects ages 13-21 years of age without re-intervention at 
6 and 12 months post-operative  
Safety Endpoints:
 
Device-related re-intervention 
 
All adverse events (AEs) occurring from the time of surgery 
until revision or study completion 
 
Device related AEs and serious adverse events (
) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
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 STUDY SCHEMATIC 
Table 1: Schedule of Events 
Schedule of Events
Chart Review 1,2
Screening
182 days  post-op
 6M (±91 Days) 
365 days post-op 
12M (± 91 Days ) 
Inclusion/Exclusion
X
Case History Review***
X
Implant Status3
X
X
X
VAS 
X
X
X
ROM
X
X
X
Concomitant Medications, Procedures4
*
*
*
AE Assessment
*
*
*
Study Implant Disposition
*
*
*
Serious Adverse Event (SAE) / Adverse 
Device Effect (ADE) / Device Deficiency 
(DevD) Assessment 
* 
* 
* 
End of Study/Subject disposition 
* 
* 
* 
1 Given the retrospective study design, data will be collected to the extent it is available.  
2 Informed consent/waiver of informed consent from the IRB must be obtained prior to retrospective data 
collection. 
3 Subjects who have undergone a revision procedure of the anchor will be considered terminated from the 
study from the date of the revision. Study related data will not be collected following the date of the 
revision. 
4 Any concomitant medications/ procedures associated with an AE, SAE or SADE will be recorded. 
* If applicable 
***  Review of subject demographics, medical history, operative, post-operative, discharge, and cumulative 
 
 
 
 
 

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CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
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 TABLE OF CONTENTS 
 
Signatures ............................................................................................................................................ 2 
1.1 
Protocol Signature Page ................................................................................................................ 2 
1.2 
Sponsor Approval ...................................................................................................................... 3 
 
Synopsis .............................................................................................................................................. 4 
 
STUDY SCHEMATIC ............................................................................................................................... 7 
 
Table of Contents ................................................................................................................................. 8 
4.1 
Table of Tables ........................................................................................................................... 10 
4.2 
Table of Figures .......................................................................................................................... 10 
4.3 
List of Abbreviations ................................................................................................................... 10 
 
Introduction ....................................................................................................................................... 13 
5.1 
Background ............................................................................................................................... 13 
5.2 
Study Purpose ............................................................................................................................ 14 
5.3 
Safety Considerations ................................................................................................................. 15 
 
Study Related Risks ............................................................................................................................ 15 
6.1 
Study Possible risks .................................................................................................................... 15 
6.2 
Study Related Benefits ................................................................................................................ 15 
 
Objective(s) ....................................................................................................................................... 15 
7.1 
Primary Objective ....................................................................................................................... 15 
 
Study Product(s) ................................................................................................................................. 15 
8.1 
Identification ............................................................................................................................. 16 
8.2 
Product Use ............................................................................................................................... 18 
8.3 
Surgical Technique ..................................................................................................................... 18 
 
Subject Enrollment and Withdrawal..................................................................................................... 18 
9.1 
Subject Population ..................................................................................................................... 18 
9.2 
Inclusion Criteria ........................................................................................................................ 19 
9.3 
Exclusion Criteria........................................................................................................................ 19 
9.4 
Screening .................................................................................................................................. 19 
9.5 
Informed Consent ...................................................................................................................... 20 
9.6 
Enrollment ................................................................................................................................. 21 
9.7 
Lost to Follow-Up ....................................................................................................................... 21 

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CONFIDENTIAL AND PROPRIETARY 
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intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
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9.8 
Withdrawal ................................................................................................................................ 21 
 
Study Design ...................................................................................................................................... 22 
10.1 
Study Design .............................................................................................................................. 22 
10.2 
Study Endpoints ......................................................................................................................... 23 
10.3 
Methods Used to Minimize Bias and Maximize Validity ................................................................. 24 
 
Study Procedures ............................................................................................................................... 25 
11.1 
Visits and Examinations .............................................................................................................. 25 
11.2 
Study Methods and Measurements ............................................................................................. 28 
 
Statistical Design ................................................................................................................................ 29 
12.1 
General ..................................................................................................................................... 29 
12.2 
Analysis Populations ................................................................................................................... 29 
12.3 
Efficacy Analysis ......................................................................................................................... 29 
12.4 
Safety Analyses .......................................................................................................................... 30 
 
Sample Size Justification ..................................................................................................................... 31 
 
Adverse Events and Device Deficiencies ............................................................................................... 31 
14.1 
Definitions ................................................................................................................................. 32 
14.2 
Reporting Procedures ................................................................................................................. 34 
14.3 
Follow-up of Subjects with Adverse Events ................................................................................... 37 
 
Investigator Obligations ...................................................................................................................... 37 
 
Sponsor and Monitor Responsibilities .................................................................................................. 38 
16.1 
Site Qualification Visit ................................................................................................................. 38 
16.2 
Site Initiation Visit ...................................................................................................................... 38 
16.3 
Sponsor Audits and Regulatory Inspection ................................................................................... 38 
16.4 
Close-out Visit ............................................................................................................................ 39 
 
Protocol Amendments ........................................................................................................................ 39 
 
Confidentiality of the Study ................................................................................................................. 39 
 
Statements of Compliance .................................................................................................................. 39 
 
End of Study ...................................................................................................................................... 39 
 
Publication Policy ............................................................................................................................... 40 
21.1 
Publication of Study Data ............................................................................................................ 40 
21.2 
Data Sharing .............................................................................................................................. 40 

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CONFIDENTIAL AND PROPRIETARY 
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intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
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References ......................................................................................................................................... 41 
 
Appendices ........................................................................................................................................ 44 
23.1 
Instructions For Use ................................................................................................................... 44 
23.2 
Principal Investigator Obligations (ISO14155) ............................................................................... 45 
23. 3            PROTOCOL AMENDMENT #1 .............................................................................................................. 54 
4.1 
TABLE OF TABLES  
Table 8.1-1: Product performance, structural composition and specification model of device .............................. 17 
Table 11.1-1: Study Procedures by Visit ........................................................................................................... 25 
Table 14.1-1: Categories of Adverse Event ....................................................................................................... 32 
 
4.2 
TABLE OF FIGURES 
Figure 14.2-1: Evaluation and Reporting of AE and DevD ................................................................................... 36 
 
4.3 
LIST OF ABBREVIATIONS  
Abbreviation 
Definition 
ADE 
Adverse Device Effect(s) 
AE 
Adverse Event(s) 
AOL 
Activities of Daily Living 
CRF 
Case Report Form(s) 
CSR 
Clinical study Report 
CTA 
Clinical Trial Agreement 
CV 
Curriculum Vitae 
DevD 
Device Deficiency(ies) 
FU 
Follow-Up 

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CONFIDENTIAL AND PROPRIETARY 
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intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
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Abbreviation
Definition
GCP
Good Clinical Practice
IBT
Iliotibial Band Syndrome
ICF
Informed Consent Form
ICH
International Conference on Harmonisation 
ICMJE
International Committee of Medical Journal Editors
IFU
Instructions for Use
IP
Investigational Product
IRB
Institutional Review Board
ISF
Investigator Site File
ISO
International Organization for Standardization
LCL
Lateral Collateral Ligament
MCL
Medial Collateral Ligament
MEDDEV
MasterControl European Medical Device Vigilance System
MDD 
Medical Device Directive 
NA or N/A 
Not Applicable 
NSAIDs 
Nonsteroidal anti-inflammatory drugs 
NSAE 
Non-Serious Adverse Event(s) 
PI 
Principal Investigator 
PP 
Per-Protocol Population 
ROM 
Range of Motion 
S&N 
Smith & Nephew, Inc. 
SADE 
Serious Adverse Device Effect(s) 
SAE 
Serious Adverse Event(s) 
SAF 
Safety population 
SAP 
Statistical Analysis Plan 

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CONFIDENTIAL AND PROPRIETARY 
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intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
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Abbreviation
Definition
SLAP
Superior Labral Tear from Anterior to Posterior
UHMWPE
Ultra-high molecular weight polyethylene
USADE
Unanticipated Serious Adverse Device Effect(s)
VAS
Visual Analog Scale
VMO
Vastus Medialis Obliquus 

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intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
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INTRODUCTION 
5.1 
BACKGROUND  
Bone anchor fixation devices are typically indicated for a variety of repairs in the shoulder, elbow, 
hand/wrist, hip, knee and foot/ankle. There are numerous alternative therapy options associated with 
these indications including conservative therapies such as rest, nonsteroidal anti-inflammatory 
drugs (NSAIDs), injection of steroids with lidocaine, and physical therapy. Several clinical studies were 
identified that reported higher clinical outcomes, or the ability to return to previous level of activity 1,2 , 
or lower complication/reinjury rate 2,3 in patients that were treated surgically rather than conservatively. 
When conservative therapy does not offer relief of symptoms for the patient, surgical intervention is 
often recommended. One method of surgical intervention is to repair using an implant such as an 
interference screw or suture anchor. Interference screws provide a press fit between bone to bone, or 
bone to graft/tendon whereas suture anchors approximate soft tissue with an implant embedded in the 
bone. The use of suture anchors may provide advantages such as reduced operative time, ease of access 
to the site of implantation, improved suture material, decreased stress along the suture line, greater 
repair strength, and improved consistency of load-to-failure characteristics 4-7. Patient bone density, 
repair location, potential allergies, the operation being performed and surgeon preference determine 
the size, type and composition of the anchor needed to secure the soft tissue to the bone 8.  
 
Non-absorbable, soft suture anchors have recently been introduced for use in arthroscopic or open soft 
tissue to bone reattachment. Soft suture anchors or all-suture anchors are completely suture-based 
implants. The anchors usually come with single or double loaded suture options. Soft anchors are 
usually smaller than hard anchors; hence the volume of bone removed is less, which is especially helpful 
should subsequent revision be necessary9-10. Additionally, the small size enables placement of anchors in 
very close proximity to each other allowing multiple sutures/fixation points per unit area of soft tissue9. 
The few studies that have investigated all-suture anchor biomechanics, such as cyclic loading and pullout 
mechanics, suggest that they are comparable to traditional anchors10-13. Soft anchors have also been 

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CONFIDENTIAL AND PROPRIETARY 
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intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
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reported to provide a comparable, or even higher, mechanical strength than that measured for the 
interference screw technique14. 
 
Typically, manufacturers of anchor systems market suture anchors preloaded with suture(s) that the 
anchor has been designed and tested wit
will specify the type of suture and how many strands may be used with an anchor. Suture anchors are 
continuously evolving to improve anchor strength and to facilitate arthroscopic or open procedures. Soft 
suture anchors are the newer anchors on the market that have pursued fixation differently with the all-
suture design. The JuggerKnot 1.4 was the first all-suture construct that was designed to avoid potential 
sequalae from the migration and third body wear of a rigid anchor body, to provide radiographic images 
unobscured by metal hardware, and to facilitate revision procedures. The small 1.4 mm diameter of the 
drill hole helps to minimize compromise to the bone while allowing for multiple points of soft tissue 
fixation15.  
 
Based on the injury type and the anatomical position of the injury, the single- and double-loaded Q-Fix  
Suture Anchor designs offer the surgeon more flexibility when determining the type of repair. The 
smaller footprint required by these devices allows the placement of multiple implants in a limited area, 
which promotes greater tissue-to-bone contact. 
 
A summary of known and potential risks and benefits to humans can be found in the IFU. 
5.2 
STUDY PURPOSE 
Post-market clinical follow-up needed to address existing clinical data and gaps on the existing Q-Fix  
device and meet existing MDD/MEDDEV requirements. 

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CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
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5.3 
SAFETY CONSIDERATIONS 
The Q-Fix  All- Suture Anchor System is intended to be used for soft tissue to bone fixation in the 
Shoulder, Knee, and Hip. Representative language of the contraindications and potential adverse effects 
from the Q-Fix  All-Suture Anchor can be found in the Instructions for Use (IFU). Cleaning and 
Sterilization Language can be found on the Reusable Surgical Instruments IFU.  
 STUDY RELATED RISKS 
6.1 
STUDY POSSIBLE RISKS 
As a result of participating in the study, there could be a risk of loss of protected subject information 
confidentiality. All applicable confidentiality standards and data protection and privacy laws will be 
followed by the Sponsor to ensure that data collected is handled in confidence. Data will be coded and 
handled only by appropriately qualified and authorized personnel. 
6.2 
STUDY RELATED BENEFITS 
Because the surgery and all the follow-up visits are the same as if the subject would not participate in 
this study, there are no additional medical benefits associated with participating in this study. The 
information gained from this study may help improve the treatment of people that need to undergo any 
of the procedures included in this study. 
 
OBJECTIVE(S) 
7.1 
PRIMARY OBJECTIVE 
 The primary objective of this study is to assess the safety and performance of the Q-
-Suture 
Anchor System.  
 
STUDY PRODUCT(S) 

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contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
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8.1 
IDENTIFICATION  
8.1.1 Indications 
The Q-Fix
All-Suture Anchor System is intended to be used for soft tissue to bone fixation for: 
 
Shoulder: Bankart lesion repair; superior labral tear from anterior to posterior( SLAP) lesion 
repair; acromio-clavicular repair; capsular shift/capsulolabral reconstruction; deltoid repair; 
rotator cuff repair; biceps tenodesis. 
 
Hip: Acetabular labral repair. 
 
Knee: Extra-capsular repair: medial collateral ligament (MCL), lateral collateral ligament (LCL) 
and posterior oblique ligament; Iliotibial band tenodesis (IBT); patellar tendon repair; vastus 
medialis obliquus advancement (VMO); joint capsule closure 
Note: Foot, ankle, elbow, hand and wrist indications are not included in the above list as data will not be 
collected.  As the study is collecting real world data retrospectively, data may be collected on the 
shoulder, knee, or hip beyond the indications listed above.      
8.1.2 Device Information 
The Q-Fix
All-Suture Anchor System also known as the Q-Fix
Soft Suture Anchor System/ Q-Fix
Soft 
Suture Anchor/ Q-Fix
Suture Anchor is available in 1.8 mm (single suture loaded) and 2.8 mm (double 
suture loaded) sizes; is manufactured from braided polyester with ultra-high molecular weight 
polyethylene (UHMWPE) suture; and is pre-loaded into a disposable tool designed to facilitate direct 
insertion into a pre-drilled or pre-punched bone hole. Table 8.1-1 demonstrates the model, 
specifications, dimensions and product description of the Q-Fix
- Suture Anchor System.  
 
The Q-Fix
MINI Suture Anchor minimizes bone removal by shortening the drill tunnel depth by 5mm. 
This drill depth of 17.1mm is approximately 23% shorter than the existing Q- Fix
1.8mm anchor. 
 

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CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
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When the soft suture anchor is deployed into the predrilled/punched hole, the suture legs are 
tensioned, increasing the soft 
The soft suture nature of the anchor allows the suture to be placed in a tunnel with a smaller diameter, 
preserving more bone.  
 Table 8.1-1: Product performance, structural composition and specification model of device 
Model 
72290123 
25-1800 
25-2800 
Specification 
1.8 mm MINI 
1.8 mm 
2.8 mm 
Dimensions 
Diagram 
Product 
description 
1.8 mm wide x 10mm long  
Q-Fix  MINI All-suture 
Anchor, single-loaded with 
suture 
1.8 mm wide x 15mm long  
Q-Fix  All-suture Anchor, 
single-loaded with a #2 
 
2.8 mm  wide x 20mm long 
Q-Fix  All-suture Anchor, 
double-loaded with a #2 
 
 

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CONFIDENTIAL AND PROPRIETARY 
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intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
SOP-059 Clinical Protocols 
 
Q-Fix  Soft Suture Anchor Disposable Surgical Instruments and Instrument Kits 
The Q-Fix  Soft Suture Anchor Disposable Surgical Instruments and Instrument Kits contain sterile, 
single-use disposable devices. The kit includes a drill, a drill guide and an obturator. 
 
Q-Fix  Soft Suture Anchor Reusable Surgical Instruments 
The Pathfinders and Bone Punch devices are manufactured of surgical stainless steel with a part of the 
device including plastic. The Q-Fix  Reusable Drill Guides and Obturators are made of surgical stainless 
steel with Acetal Copolymer handles. 
 
ArthroCare Corporation is a wholly-owned subsidiary of Smith & Nephew, Inc. ArthroCare Corporation is 
the legal manufacturer of the study devices. Smith & Nephew, Inc. globally distributes the study devices 
8.2 
 PRODUCT USE 
 Each device is packaged with an IFU (62526.en) 21 to ensure that the device is used properly and for the 
intended procedures. For the purposes of this protocol, unless otherwise noted in the operative report, 
the delivery system for the device worked correctly since the device was deployed.  
8.3 
SURGICAL TECHNIQUE 
The operative visit of this study is retrospective. The use of the Q-Fix  All-Suture Anchor System was 
performed per standard of care at the participating study sites. 
 
 
SUBJECT ENROLLMENT AND WITHDRAWAL 
9.1 
SUBJECT POPULATION 
To eliminate the potential for bias, Investigators will consecutively screen subjects by date of surgery, 
starting with subjects that have undergone arthroscopic or open soft tissue repair with Q-Fix  All-Suture 

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intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
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Anchor system in the past 12 months as of the IRB approval date, or using another date as agreed upon 
by the Investigators and site. In addition, to ensure enrollment of Q-Fix
MINI subjects, a different 
enrollment start date may be selected to enroll Q-Fix
MINI subjects only.    
9.2 
INCLUSION CRITERIA 
Subjects will be considered qualified for enrollment if they meet the following criteria: 
1.
Subject has undergone arthroscopic or open soft tissue repair with Q-Fix
All-Suture Anchor 
System 
2.
Subject was
 13 of age at time of surgery
9.3 
EXCLUSION CRITERIA 
Any one (1) of the following criteria will disqualify a potential subject from participation in the study: 
1. Subject is   6 months post-operative
2. Subject is entered in another investigational drug, biologic, or device study or has been treated 
with an investigational product within 12 months post-operative. 
9.4 
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.  
 
If during screening, a subject is found to have had re-intervention of the Q-Fix  All-Suture Anchor 
system, the subject is still eligible to be enrolled in the study. Site staff will complete an End of Study Case 
Report Form (CRF) for all subjects who do not finish the study, documenting the reason for withdrawal. 

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intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
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9.5 
INFORMED CONSENT 
Study sites will obtain Institutional Review Board (IRB) approval for this study. 
An IRB waiver of informed consent for study participation should be requested for those subjects who 
meet eligibility criteria and have retrospectively completed a 12 month postoperative visit, are 
deceased, or are lost to follow-up, per IRB policy. If allowed, a retrospective data set will be collected on 
these subjects. A copy of the waiver of informed consent will be placed in the subject file. 
 
A waiver or alteration of the requirements for obtaining informed consent can occur under any of the 
following three provisions set forth by the Department of Health and Human Health Services: 
 
Research in general: an IRB may waive or alter the requirement of informed consent under 45 
CFR 46.116(d), provided that the IRB finds and documents that all of the following four 
conditions are met:  
1. the research involves no more than minimal risk to the participants; 
2. the waiver or alteration will not adversely affect the rights and welfare of the participants; 
3. the research could not practicably be carried out without the waiver or alteration; and  
4. Whenever appropriate, the participants will be provided with additional pertinent information 
after   participation. 
If an IRB waiver is not granted, then the informed consent shall be obtained from all study subjects 
according to ISO 14155 guidelines and all applicable national regulations.  Potential subjects must be 
informed as to the purpose of the study and the potential risks and benefits known or that can be 
reasonably predicted or expected as described in the written consent form. The subject, or their legally 
authorized representative, will then read, sign, and personally date the IRB approved informed consent 
document(s) (see below for difficulties with reading and writing). If the subject is an adolescent ages 13-
17 years old, a signed adolescent informed consent form will be required of the subject as well as a 

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CONFIDENTIAL AND PROPRIETARY 
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intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
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signed parental informed consent form of a parent or guardian. 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 subj
medical record, and the original filed in the Investigator Site File (ISF). 
 
If a subject refuses participation, no further information will be collected. Reason for exclusion should 
be noted on the Screening and Enrollment Log. 
9.6 
ENROLLMENT 
Enrollment in this study shall occur when subjects have met inclusion criteria and none of the exclusion 
criteria.   
For screening, only information in the medical records will be reviewed. Once a subject has completed 
the informed consent process, if required by the IRB, or a waiver of consent is granted, the subject will 
be considered enrolled and assigned a consecutive Subject Identification (ID) number.    
 
9.7 
LOST TO FOLLOW-UP 
 A subject will be considered lost to follow-up if he/she did not return to for follow-up per the study 
Investigator  standard of care.  
9.8 
WITHDRAWAL 
9.8.1 Conditions for Study Termination 
All reasonable efforts should be made to collect 12 month postoperative data on all subjects enrolled in 
this study. There are multiple reasons a subject may be terminated from the study. For each case, 
information will be obtained on the End of Study CRF, detailing circumstances leading to the withdrawal.  
9.8.1.1 
Voluntary Withdrawal 

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intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
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Study participation is voluntary and subjects may withdraw from the study without giving reason for 
doing so.  
9.8.1.2 
Study Termination by Investigator/Sponsor 
The Investigator should withdraw subjects from the study if the Investigator or the Sponsor stops the 
study for any reason 
9.8.1.3 
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.  
9.8.1.4 
Study Site Discontinuation 
A specific study site in this multicenter study may also warrant termination under the following 
conditions: 
 
non-compliance to  Good Clinical Practice (GCP) or protocol 
 
failure to enroll subjects 
 
major protocol deviations 
 
inaccurate or incomplete data 
 
unsafe or unethical practices 
 
safety or performance considerations 
 
investigator involuntarily discontinues participation in study 
 STUDY DESIGN 
10.1 
STUDY DESIGN 
This is a retrospective, multi-center, case series study to collect clinical data that will evaluate post-
market Safety and Performance of the Q-Fix
All- Suture Anchor System in the knee, shoulder and hip. 

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intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
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A minimum of 90 subjects and a maximum of 450 subjects in the United States who underwent surgery 
in the knee, shoulder or hip using the Q-Fix
All- Suture Anchor System are planned to be enrolled into 
the study after the fulfilment of all inclusion and exclusion criteria.  
 
Data from eligible subjects will have their data recorded on case report forms.  
10.2 
STUDY ENDPOINTS 
10.2.1 Primary Endpoint 
 
Clinical success rate, defined as subjects without re-intervention at 6 months post- operative, as 
assessed by the surgeon 
10.2.2 Secondary Endpoints  
 
Clinical success rate, defined as subjects without re-intervention at 12 months post- operative, as 
assessed by the surgeon 
 
VAS -pain 
 
ROM 
 
Clinical success rate in adolescents and young adults, defined as subjects ages 13-21 years of age 
without re-intervention at 6 and 12 months post-operative 
10.2.3 Safety Endpoints 
 
Device-related re-intervention 
 
All adverse events (AEs) occurring from the time of surgery until revision or study completion 
 
  

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intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
SOP-059 Clinical Protocols 
 
10.3 
METHODS USED TO MINIMIZE BIAS AND MAXIMIZE VALIDITY 
10.3.1 Multiple Sites 
Subject enrollment will be conducted using at least three sites for each indication with up to nine sites in 
total for the study. This will reduce the effect of observer bias that might arise at a particular clinical site.  
As well as maximize the range of subjects treated. 
10.3.2 Retrospective Consecutive Enrollment 
To minimize any potential for selection bias consecutive enrollment will be utilized to retrospectively 
enroll any subjects encountered that meet the inclusion/exclusion criteria. 
10.3.3 Balanced Covariates 
The inclusion/exclusion criteria will be generalizable and applicable to the widest possible subset of the 
population requiring arthroscopic or open surgery for soft tissue repair. These criteria will be uniformly 
applied so as to enroll a cohort of subjects with similar symptoms and clinical requirements. This should 
maximize the applicability to as many subjects with similar baseline characteristics and help to bolster 
external validity. 
10.3.4 Subject Attrition  
Subject attrition for the sample size has been accounted for in the estimate of the Confidence Interval so 
as to validate the analysis and most efficiently use the available subjects. 
10.3.5 Pre-specification of Statistical Analysis 
The primary outcome measure has been pre-specified as well as the type of statistical analysis to be 
performed to evaluate clinical success so as to minimize reporting bias. The details of the analysis will 
further be pre-specified in the Statistical Analysis Plan (SAP) so as minimize any threats to external 
validity and yield clinically relevant estimates of effects and precision. 

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intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
SOP-059 Clinical Protocols 
 
 
 STUDY PROCEDURES 
11.1 
VISITS AND EXAMINATIONS  
11.1.1 Summary 
For a summary of the required procedures by visit, refer to Table 11.1-1: Study Procedures by Visit. 
Table 11.1-1: Study Procedures by Visit 
Schedule of Events
Chart Review 1,2
Screening
182 days  post-op 
 6M (±91 Days) 
365 days post-op 
12M (± 91 Days ) 
Inclusion/Exclusion
X
Case History Review***
X
Implant Status3
X
X
X
VAS  
X 
X 
X 
ROM 
X 
X 
X 
Concomitant Medications, Procedures4 
* 
* 
* 
AE Assessment 
* 
* 
* 
Study Implant Disposition 
* 
* 
* 
Serious Adverse Event (SAE) / Adverse 
Device Effect (ADE) / Device Deficiency 
(DevD) Assessment 
* 
* 
* 
End of Study/Subject disposition 
* 
* 
* 
 
 
1 Given the retrospective study design, data will be collected to the extent it is available.  
2 Informed consent/waiver of informed consent from the IRB must be obtained prior to retrospective data 
collection. 

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intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
SOP-059 Clinical Protocols 
 
3 Subjects who have undergone a revision procedure of the anchor will be considered terminated from the 
study from the date of the revision. Study related data will not be collected following the date of the revision. 
4 Any concomitant medications/ procedures associated with an AE, SAE or SADE will be recorded. 
* If applicable 
*** Review of subject demographics, medical history, operative, post-
occurring since date of surgery 

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intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
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11.1.2 Retrospective: Screening  
Given the retrospective study design, data will be collected to the extent it is available. 
 
Obtain informed consent, as required by the IRB, on and IRB approved ICF or a waiver of 
informed consent as detailed in Section 9.5 
----- Do not proceed until consent has been obtained ----- 
 
Screen the subject for protocol inclusion/exclusion criteria.
 
Assign the subject a subject ID
 
records, per CRF completion guidelines: 
o Case History Review (Review of subject demographics, medical history, operative, 
post-operative
 
o Implant status 
o VAS (pain)  preoperative if available 
o ROM - preoperative if available 
 
Implant Status CRF, if applicable 
 
Study Implant Disposition CRF, if applicable 
 
AE  assessments- if applicable 
 
Concomitant medications/ procedures associated with an AE, SAE or SADE will be recorded- if 
applicable 
 
End of Study CRF, if applicable 
11.1.3 Retrospective Data Collection: 6 Months Post-Operative (±91 Days) 
Given the retrospective study design, data will be collected to the extent it is available 
 
 
VAS (pain)  post-operative if available 

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contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
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TMP-110  Clinical Protocol - Devices  
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ROM - post-operative-operative if available
 
Implant Status CRF, if applicable
 
Study Implant Disposition CRF, if applicable
 
AE  assessments- if applicable
 
Concomitant medications/ procedures associated with an AE, SAE or SADE will be recorded- if 
applicable 
 
End of Study CRF, if applicable
11.1.4 Retrospective: 12 Months Post-Operative (±91 days) 
VAS (pain) post-operative if available
ROM- post-operative-operative if available
Implant Status
Study Implant Disposition CRF, if applicable 
AE  assessments- if applicable 
Concomitant medications/ procedures associated with an AE, SAE or SADE will be recorded- if 
applicable 
End of Study CRF, if applicable 
11.2 
STUDY METHODS AND MEASUREMENTS 
All Subjects 
 
VAS pain assessment* 
 
ROM assessment* 
*Patient Reported Outcomes (PROs) are optional and used according to the Investigator
 

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contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
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TMP-110  Clinical Protocol - Devices  
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 STATISTICAL DESIGN 
An 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. 
12.1 
GENERAL 
or designee will conduct the statistical analysis for this 
study. Unless otherwise stated, all significance tests will be two-sided, performed at the 5% significance 
level. Resulting p-values will be quoted and 95% two-sided confidence intervals will be generated where 
appropriate.  
 
Where data summaries are specified, categorical and ordinal variables will be summarized with 
frequencies and percentages. Continuous variables will be summarized with the following summary 
statistics: number of observations, mean, median, standard deviation, minimum and maximum values. 
All analyses will be performed in SAS 9.3 (or later). 
12.2 
ANALYSIS POPULATIONS 
The following analysis populations will be used for this study: 
 
Safety Population (SAF): This includes all subjects who enroll in the study who had previously 
undergone arthroscopic or open soft tissue repair using the Q-
-Suture Anchor System i.e. 
subjects who only provide retrospective data.  
 
Per-Protocol Population (PP): This includes all subjects in the Safety Population, who have no 
significant protocol deviations and who meet all the inclusion/exclusion criteria. 
12.3 
EFFICACY ANALYSIS 
12.3.1 Analysis of Primary Endpoint(s) 

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TMP-110  Clinical Protocol - Devices  
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Clinical success rate, defined as subjects without re-intervention at 6 months post-operative, as assessed 
by the surgeon: 
The frequency of the subjects without re-intervention at 6 months together with percentage with a 95% 
CI will be reported. Clinical success rate for the entire sample, as well as by the position (i.e. the hip, 
shoulder and knee will be reported). This analysis will be carried out using the per protocol population 
as the primary analysis population with the safety population used for sensitivity analysis. 
12.3.2 Analysis of Secondary Endpoint(s) 
Clinical success rate, defined as subjects without re-intervention at 12 months post-operative, as 
assessed by the surgeon. The same type of analysis carried out on the primary endpoint would be 
implemented here as well. 
 
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 the indication will be 
reported. 
 
Clinical success rate on adolescents and young adults, defined as subjects ages 13-21 without re-
intervention at 6 and 12 months post-operative, as assessed by the surgeon. The same type of analysis 
carried out on the primary endpoint would be implemented here as well. 
 
 Available data will be summarized and summary statistics tabulated. 
12.4 
SAFETY ANALYSES 
All safety analyses will be conducted using the safety population. The number of incidences and number 
of subjects reporting all adverse events will be summarized both overall and by seriousness, severity, 

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TMP-110  Clinical Protocol - Devices  
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relationship to study device and outcome. Incidences and number of subjects reporting device 
deficiencies will also be summarized. Further summaries of safety data may be described in the SAP. 
 SAMPLE SIZE JUSTIFICATION 
 Precision Analysis will be used to assess the overall proportion of success for the Q-Fix
All-Suture 
Anchor System. Then assuming a 5% lost to follow-up rate after the first year, a minimum of 90 subjects 
will be enrolled (based on the inclusion/exclusion criteria) in order to complete 84 evaluable subjects. 
The 90 subjects will be enrolled to allow a minimum of 28 patients with each of the following indications 
to be recruited: Shoulder, Hip and Knee. Based on the results of the Byrd et al25 study which showed an 
failure rate of 1.6% in the use of the Q-Fix
-Suture Anchor System, this number of subjects is 
sufficient to estimate the proportion of success rate to within 11% by use of the two-sided 95% 
confidence interval (based on an estimate of the rate of clinical success being 95%). 
 ADVERSE EVENTS AND DEVICE DEFICIENCIES 
Adverse Events (AE) related to the study implant, or procedure including Adverse Device Effects (ADE), 
Serious Adverse Device Effects (SADE), Unanticipated Serious Adverse Device Effect (USADE), and Device 
Deficiencies (DevD) occurring from the time of the surgery until revision or study completion must be 
recorded on the appropriate CRF and reported. If the event is known to have been previously reported 
to Smith & Nephew, this must be noted on the CRF.  After consent, in addition to all events related to 
the implant or the procedure, all serious adverse events (SAE), regardless of causality, must be recorded 
on the appropriate CRF and reported to the Sponsor and IRB if necessary. Events leading to a revision 
should be reported at all times regardless of causality.   
 
Adverse Device Effects (ADE) occurring after study completion will be handled as product complaints 
reportable by the Sponsor and will not be entered into the study database. 
 

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TMP-110  Clinical Protocol - Devices  
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14.1 
DEFINITIONS 
The categories of adverse events are shown in table 14.1-1. The definitions for each of these categories 
are given in the subsequent sections (see reference within the table).  
Table 14.1-1: Categories of Adverse Event 
NOT DEVICE- RELATED
DEVICE- OR PROCEDURE-RELATED
NON-
SERIOUS 
ADVERSE EVENT  
(AE) (SEE 14.1.1) 
ADVERSE DEVICE EFFECT  
(ADE) (SEE 14.1.2) 
SERIOUS 
SERIOUS ADVERSE EVENT  
(SAE)  
(SEE 14.1.3) 
SERIOUS ADVERSE DEVICE EFFECT
(SADE) (SEE 14.1.3) 
ANTICIPATED
UNANTICIPATED
ANTICIPATED SERIOUS ADVERSE 
DEVICE EFFECT  
(ASADE) (SEE 14.1.4) 
UNANTICIPATED SERIOUS 
ADVERSE DEVICE EFFECT   
(USADE) (SEE 14.1.4) 
14.1.1 Adverse Event 
An AE is any untoward medical occurrence temporally associated with the use of an Investigational 
Product (IP)/Ancillary Product, whether or not considered causally related to that IP/Ancillary Product.  
AE is used both to refer to AEs which are non-serious non-IP or procedure-related and as an umbrella 
term referring to adverse events of all classifications.  
14.1.2 Adverse Device Effect 
An 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; 

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CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
SOP-059 Clinical Protocols 
 
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 14.1.3 and 14.1.4 are met. 
14.1.3 Serious Adverse Events and Serious Adverse Device Effects  
An AE or ADE is considered a SAE or SADE if, in the view of either the Investigator or the Sponsor, it: 
 
Results in death. 
 
Is life-threatening (NOTE
-
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. 
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. 
14.1.4 Anticipated/Unanticipated Serious Adverse Device Effect 

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CONFIDENTIAL AND PROPRIETARY 
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intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
SOP-059 Clinical Protocols 
 
An 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.  
An Anticipated Serious Adverse Device Effect (ASADE) is a serious ADE that does not meet the criteria 
for a USADE.  
14.1.5 Severity  
The severity of every AE will be assessed by the Investigator 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 
 
Severe -   An event is severe if the sign or symptom is incapacitating and results in the 
inability 
to work or engage in their usual activities. 
14.1.6 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.  
14.2 
REPORTING PROCEDURES 
AEs of any kind and DevDs will be recorded in the applicable CRF and source notes. The Investigator will 
evaluate all AEs for relationship to the device and procedure, if applicable, seriousness, and severity. 

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CONFIDENTIAL AND PROPRIETARY 
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intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
SOP-059 Clinical Protocols 
 
ADEs, SAEs, and DevDs will be submitted/entered into the CRF and reported to the Sponsor within 24 
hours of the Investigator being informed about the event (Figure 14.2-1). For ADEs and DevDs, 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 the sponsor 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 SAEs and ADEs 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 of AEs according to the IRB requirements.  
 
Depending on the nature of the AE, the Sponsor may request copies of the 
, 
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 the Sponsor and should be forwarded as soon as it becomes available. In certain cases, 
the Sponsor also may request a letter from the Investigator that summarizes the events related to the 
case. 

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CONFIDENTIAL AND PROPRIETARY 
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intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
SOP-059 Clinical Protocols 
 
Figure 14.2-1: Evaluation and Reporting of AE and DevD  
 
 
Reference the Investigator Site File Sponsor Contact Information Sheet to report SAEs, unanticipated 
ADEs and SADEs, anticipated SADEs, and DevDs.
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 
medical 
records / 
source notes.
Device 
Deficiency 
Record information 
in patient CRF 
according to usual 
timescales.
Stop

 
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CONFIDENTIAL AND PROPRIETARY 
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intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
SOP-059 Clinical Protocols 
 
14.3 
FOLLOW-UP OF SUBJECTS WITH ADVERSE EVENTS 
For subjects who are experiencing an 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. 
14.3.1 Ongoing Adverse Events at Study Discontinuation 
Adverse events which are related to a study procedure or IP 
participation: The event should be followed until it is either resolved or until the event has become 
 
Adverse events which are not related to a study procedure or IP and are 
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 
The Principal Investigator (PI) will comply with the commitments outlined in the in the Statement of 
Investigator and with GCP, and all applicable regulatory requirements as outlined in Appendix 23.2 of 
this protocol. 
 
 

 
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CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
SOP-059 Clinical Protocols 
 
 SPONSOR AND MONITOR RESPONSIBILITIES 
 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.  
16.1 
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. 
16.2 
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 Clinical Trial Agreement (CTA) and documented IRB approval.  
16.3 
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.  

 
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CONFIDENTIAL AND PROPRIETARY 
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intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
SOP-059 Clinical Protocols 
 
16.4 
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, confirm the disposition of 
any other ancillary items used for the study, and review regulatory requirements regarding records 
retention and IRB/IEC reporting requirements.  
 PROTOCOL AMENDMENTS 
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. Protocol 
amendments need to be approved by the IRB and Regulatory Authority(ies), as applicable prior to 
implementation at the site 
 CONFIDENTIALITY OF THE STUDY 
The confidentiality of this study and associated documents is governed by the terms of the CTA. 
 STATEMENTS OF COMPLIANCE 
This clinical study will be performed in compliance with the ethical principles of the Declaration of 
Helsinki; International Organization for Standardization (ISO) 14155: Clinical investigation of medical 
devices  Good Clinical Practice (GCP); and the International Council for Harmonisation (ICH)-E6. 
 
This clinical study will not commence until the required approval/favorable opinion from the IRB or 
regulatory authority has been obtained. Any additional requirements imposed by the IRB or regulatory 
authority will be followed.  
 END OF STUDY 

 
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contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
SOP-059 Clinical Protocols 
 
Should circumstances arise which require the termination of the entire study prior to its planned 
completion (e.g. safety concerns) or circumstances arise which mean the end of the participation of an 
individual site (e.g. departure of Investigator, non-compliance), then this will be undertaken according to 
the Standard Operating Procedures (SOP) of the Sponsor.  
 PUBLICATION POLICY 
21.1 
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 
21.2 
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 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 the Sponsor.  To gain access, data requestors will need to sign a data 
access agreement. 

 
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contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
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 REFERENCES 
1.  Fitzgerald GK, Axe MJ, Snyder-Mackler L. A decision-making scheme for returning patients to 
high-level activity with nonoperative treatment after anterior cruciate ligament rupture. Knee 
surgery, sports traumatology, arthroscopy: official journal of the ESSKA. 2000; 8(2):76-82.  
2. Kim SH, Ha KI, Kim SH. Bankart repair in traumatic anterior shoulder instability: open versus 
arthroscopic technique. Arthroscopy: the journal of arthroscopic & related surgery: official 
publication of the Arthroscopy Association of North America and the International Arthroscopy 
Association. Sep 2002; 18(7):755-763.  
3. Arciero RA, Wheeler JH, Ryan JB, McBride JT. Arthroscopic Bankart repair versus nonoperative 
treatment for acute, initial anterior shoulder dislocations. Am J Sports Med. Sep-Oct 1994; 
22(5):589-594.  
4. Kerin C, Hopgood P, Banks A. Delayed repair of the quadriceps using the Mitek anchor system: a 
case report and review of the literature. The Knee. 2006; 13(2):161-163.  
5. Lemos SE, Ebramzedeh E, Kvitne RS. A New Technique In Vitro Suture Anchor Fixation Has 
Superior Yield Strength to Bone Tunnel Fixation for Distal Biceps Tendon Repair. The American 
Journal of Sports Medicine. 2004; 32(2):406-410.  
6. Maniscalco P, Bertone C, Rivera F, Bocchi L. A new method of repair for quadriceps tendon 
ruptures. A case report. Panminerva medica. Sep 2000; 42(3):223-225.  
7. Richards DP, Barber FA. Repair of quadriceps tendon ruptures using suture anchors. Arthroscopy: 
The Journal of Arthroscopic & Related Surgery. 2002; 18(5):556-559.  
8. Efird C, Traub S, Baldini T, et al. Knotless single-row rotator cuff repair: a comparative 
biomechanical study of 2 knotless suture anchors. Orthopedics. Aug 2013; 36(8):e1033-1037.  
9. Agrawal V. Clinical Outcomes of the JuggerKnot Soft Anchor for Shoulder Repair. Biomet 
webpage: Form No. BMET0230.0 Rev111512. 2012.  
10. McKenzie B, Moore C. Mechanical performance of the SUTUREFIX Ultra soft suture anchor for 
shoulder labral repair. Bone&JointScience. 2014.  

 
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CONFIDENTIAL AND PROPRIETARY 
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intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
SOP-059 Clinical Protocols 
 
11. Barber FA, Herbert MA. Cyclic loading biomechanical analysis of the pullout strengths of rotator 
cuff and glenoid anchors: 2013 update. Arthroscopy: the journal of arthroscopic & related 
surgery: official publication of the Arthroscopy Association of North America and the 
International Arthroscopy Association. May 2013; 29(5):832-844.  
12. Galland A, Airaudi S, Gravier R, Le Cann S, Chabrand P, Argenson JN. Pullout strength of all suture 
anchors in the repair of rotator cuff tears: a biomechanical study. International orthopaedics. Oct 
2013; 37(10):2017-2023.  
13. Goschka AM, Hafer JS, Reynolds KA, et al. Biomechanical comparison of traditional anchors to 
all-suture anchors in a double-row rotator cuff repair cadaver model. Clin Biomech (Bristol, 
Avon). Jun 14 2015.  
14. Mazzocca AD, Chowaniec D, Cote MP, et al. Biomechanical evaluation of classic solid and novel 
all-soft suture anchors for glenoid labral repair. Arthroscopy: the journal of arthroscopic & 
related surgery: official publication of the Arthroscopy Association of North America and the 
International Arthroscopy Association. May 2012; 28(5):642-648.  
15. Agrawal V, Pietrzak WS. Triple labrum tears repaired with the JuggerKnot soft anchor: Technique 
and results. Int J Shoulder Surg. Jul-Sep 2015; 9(3):81-89. 
16. Brown CA, Hurwit D, Behn A, Hunt KJ. Biomechanical comparison of an all-soft suture anchor 
with a modified Brostrom-Gould suture repair for lateral ligament reconstruction. Am J Sports 
Med. Feb 2014; 42(2):417-422.  
17. Hirzinger C, Resch H, Schauer J. A perilunate dislocation with the hand in a 90° radial deviation. 
Sports Orthopaedics and Traumatology Sport-Orthopädie-Sport-Traumatologie. 2015. 
18. Prasathaporn N, Kuptniratsaikul S, Kongrukgreatiyos K. Arthroscopic Lateral Meniscus Root 
Repair with Soft Suture Anchor Technique. Arthroscopy techniques. 2013; 2(4):e479-e482. 
19. Koga H, Muneta T, Yagishita K, et al. Arthroscopic centralization of an extruded lateral meniscus. 
Arthrosc Tech. Dec 2012; 1(2):e209-212. 

 
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CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
SOP-059 Clinical Protocols 
 
20. 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.  
21. IFUs. 62526.en_A, 62529.en_A, and 62533.en_A.  
22. ISO 14155:2011 Clinical investigation of medical devices for human subjects  good clinical 
practice. 
23. ISO 14155:2011 Clinical investigation of medical devices for human subjects  good clinical 
practice. 
24. Taichman, DB, et al. Data Sharing Statements for Clinical Trials: A Requirement of the 
International Committee of Medical Journal Editors. Ann Intern Med. 2017. 6th June. 
doi:10.7326/M17-1028 
25. Byrd, J.W. Thomas, Kays S, et al. Acetabular All-Suture Anchor for Labral Repair: Incidence of 
Intraoperative Failure due to Pullout. Arthroscopy: The Journal of Arthroscopic & Related 
Surgery, Volume 34, Issue 4, April 2018, Pages 1217-1218 
26. U.S. Department of Health and Human Services (HHS) Code of Federal Regulation Title 45 Part 46  
(45 CFR 46)  Revised January 15, 2009  
 
 
 

 
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contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
SOP-059 Clinical Protocols 
 
 APPENDICES 
23.1 
INSTRUCTIONS FOR USE 
Always refer to the Q-Fix  All-Suture Anchor System IFU.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
SOP-059 Clinical Protocols 
 
 
23.2 
PRINCIPAL INVESTIGATOR OBLIGATIONS (ISO14155) 
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, 

 
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is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
SOP-059 Clinical Protocols 
 
b. 
comply with the requirements described in 4.5 of ISO 14155: 
i. 
Submit to the IEC the following information, any amendments and any additional 
documentation required by the IEC: the Protocol; IB or equivalent; informed 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. 
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 

 
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CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
SOP-059 Clinical Protocols 
 
2. 
Approval of the request for deviations that can affect the su
, 
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, 
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 
representative:  
i. 
Ensure that the PI or his/her authorized designee conducts the informed consent process 
ii. 
Include all aspects of the clinical 
to participate throughout the clinical investigation 

 
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CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
SOP-059 Clinical Protocols 
 
iii. 
Avoid any coercion or undue improper influence on, or inducement of, the subject to 
participate 
iv. 
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 
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 

 
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CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
SOP-059 Clinical Protocols 
 
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 
informed 
be requested.  
2. 
When it is not possible to obtain prior informed consent from the subject, and the 
till 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
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 
authorized 
representative): 

 
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CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
SOP-059 Clinical Protocols 
 
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 
viii. 
Information on the role of Sponsor
 
ix. 
Contact persons 
x. 
Statement declaring that new findings or the reasons for any amendment to the protocol 
e made available to the subject.  
xi. 
 
xii. 
Termination procedures 
f. 
Informed consent signature shall contain the following:  
i. 
The voluntary agreement to participate in the clinical investigation and follow the 
 
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 
questions were answered 
vi. 
A statement confirming that the subject or his/her legally authorized representative 
investigation 

 
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CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
SOP-059 Clinical Protocols 
 
vii. 
A statement confirming that the subject or his/her legally authorized representative 
agrees that Sponsor
IEC representatives will 
 
g. 
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 
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, 

 
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CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
SOP-059 Clinical Protocols 
 
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 
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 

 
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CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
SOP-059 Clinical Protocols 
 
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, 
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. 
 
 
 

 
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CONFIDENTIAL AND PROPRIETARY 
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intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
SOP-059 Clinical Protocols 
 
23.3  PROTOCOL AMENDMENT #1 
 
General Purpose 
The purpose for this amendment is to:   
1) Decrease age limit to >13 years to include adolescents as it was determined that the Q-Fix  anchor is 
being used by sites in adolescents; it is important to obtain information on the safety and performance in 
the adolescent population as well as in adults. A secondary objective is added so that an analysis may be 
done on adolescents and young adults ages 13-21 years of age. As this retrospective study is granted a 
waiver of informed consent for adults, it is requested for adolescents as well. 
2) Increase enrollment maximum to 450 subjects to allow for the enrollment of adolescents and 
additional Q-Fix  MINI subjects (150 maximum per joint type.) 
3) Revise the timeline to account for the enrollment of adolescents; this amendment is not expected to 
affect the overall study duration.  
4) Include both open and arthroscopic surgeries in the study as it was determined that sites used the Q-
Fix  anchor in both arthroscopic and open soft tissue repair surgeries; it is important to obtain safety 
and performance data for both types of surgery. Also clarified that as the study is collecting real world 
safety data, use in knee, shoulder, and hip may be collected beyond the indications for use. 
5) Clarify that another enrollment date may be used if agreed upon by Investigators and site, as long as a 
bias is not introduced using this date. In addition, the enrollment start date for Q-Fix  MINI may be 
different than the start date for the 1.8 and 2.8mm Q-Fix  anchors to ensure that the data is collected 
on all 3 sizes of the Q-Fix  anchor. 
 
Rationale 
The rationale for the changes is as follows: 
1) From the screening and enrollment logs provided by the sites to the Sponsor, individuals <18 
years old are receiving Q-Fix  anchors, but this population is not included per the current 

 
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Version: 2.0 05SEP2019 
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CONFIDENTIAL AND PROPRIETARY 
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intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
SOP-059 Clinical Protocols 
 
eligibility criteria. A goal of this post-market study is to determine the safety and performance of 
the Q-Fix  anchor in populations that are receiving the Q-Fix  anchor, so by not including 
adolescents, this study is unable to analyze whether the anchor is safe and performs well in a 
population that physicians are already using the Q-Fix  anchor in: individuals aged 13 to 17 
years old. A secondary exploratory analysis will be conducted on adolescents and young adults 
ages 13-21 years of age. Given that the current processes for this retrospective study will not 
change, it is requested that a waiver of consent be extended to include the adolescent 
population as well the adult population.    
2) In order to enroll adolescents, as well as Q-Fix  MINI anchors, the study maximum is increased 
from 360 to 450 subjects (150 subjects per indication).  As the sites will be enrolling subjects that 
were originally excluded, this number is enough to include all adolescents that were previously 
excluded per the site Screening Logs.     
3) In order to enroll adolescents, data collection is increased from 12 to 16 months.  Follow-up is 
expected to take shorter than originally planned; therefore, the overall timeline for the study 
remains at 2.5 years. 
4) Physicians are already using the Q-Fix  anchor in both open and arthroscopic surgeries.  In order 
to adequately describe the safety and performance of the Q-Fix  anchor post-market, it is 
important to include both surgery types.  A protocol waiver to include these individuals was 
already granted by all IRBs; therefore, the protocol is being revised to capture this information, 
as well as clarifying that the Q-Fix  is indicated for use in soft tissue repair (not just instability). 
Additionally, clarified that as the study is collecting retrospective real world safety and 
performance data, sites may provide data on use in the shoulder, knee, or hip that is not listed in 
the indications for use.   
5) The wording on the statement for enrolling subjects is not clear and there has been confusion in 
interpreting this line by the sites
To eliminate the potential for bias, Investigators will 
consecutively screen subjects by date of surgery, starting with subjects that have undergone 
arthroscopic tissue repair with Q-Fix  All-Suture Anchor system in the past 12 months as of the 

 
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CONFIDENTIAL AND PROPRIETARY 
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intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
SOP-059 Clinical Protocols 
 
IRB approval date
sites were not selecting records to prevent bias, and therefore this was broadened to include 
that a start date may be agreed upon by the Site and Sponsor.  In addition, as the Q-Fix  MINI 
anchor was released later than the 1.8mm and 2.8mm Q-Fix  anchors, to ensure enrollment of 
MINI anchors, a more recent date will need to be used by the sites to specifically target Q-Fix  
MINI subjects.   
 
Effect on Study Status 
These changes does not affect subjects that are already enrolled and does not affect the Case Report 
Forms.  Current enrollment is 106 hip subjects, 99 shoulder subjects, and 24 knee subjects across all 5 
sites that are participating in the study.  If approval is received to enroll adolescents, the Statistical 
Analysis Plan will be revised to include adolescents to reflect the change in Secondary Endpoints.  This 
change is not expected to affect the overall timeline of 2.5 years, however, enrollment is expected to 
require 16 months rather than 12 months and follow-up was decreased from 6 months to 2 months. 

 
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intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
SOP-059 Clinical Protocols 
 
 
Details  
 
Section
 
Current Text 26JUN2018 Version 1.0
 
Revised Text 05SEP2019 Version 2.0
Heading
Version: 1.0 26JUN2018
Version: 2.0 05SEP2019 
1.1 Protocol 
Signature Page 
I have read the attached protocol 
Safety and Performance of 
Q-
-
 
version 1.0, dated 26June2018, and 
agree to abide by all provisions set 
forth herein. I have read the attached 
Safety and 
Performance of Q-
-Suture 
 version 2.0, dated 
05SEP2019, and agree to abide by all 
provisions set forth herein. 
I agree to comply with the 
tions stipulated in 
Section 15.0 of the protocol.   
I have read the attached protocol 
-
-
2.0, dated 05SEP2019, and agree to 
abide by all provisions set forth herein. I 
have read the attached protocol entitled 
Safety and Performance of Q-
-
 2.0, 
dated 05SEP2019, and agree to abide by 
all provisions set forth herein. 
I agree to comply with 
Obligations stipulated in Section 15.0 of 
the protocol.  
1.2 Sponsor 
Approval 
Head of Global Clinical 
Operations 
Shirley Mak-Parisi, Regional 
Operations Manager 

 
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intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
SOP-059 Clinical Protocols 
 
Head of Global Clinical 
Strategy 
Head of Global Biostatistics 
Medical Affairs Representative 
 
Stephan Mangin, Clinical 
Strategy Lead 
Alan Rossington, Head of 
Global Biostatistics 
Luca Orlandini, Medical Affairs 
Representative 
 
2. Synopsis  
Sample Size 
A total minimum sample size of 90 
subjects is proposed with a maximum 
of 360 subjects (depending on market 
share) for approved joint indications. 
 
Maximum 120 
A total minimum sample size of 90 
subjects is proposed with a maximum of 
450 subjects (depending on market 
share) for approved joint indications. 
 
Maximum 150 
2. Synopsis 
Inclusion Criteria 
1. Subject has undergone arthroscopic 
instability repair with Q-Fix  All-
Suture Anchor System 
1. Subject has undergone arthroscopic or 
open soft tissue repair with Q-Fix  All-
Suture Anchor System 
2. Subject was   13 of age at time of 

 
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contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
SOP-059 Clinical Protocols 
 
2. Subject was
 18 of age at time of 
surgery 
surgery
2. Synopsis
Study Duration 
12 months for subject enrollment
6 months for follow-up 
16 months for subject enrollment
2 months for follow-up 
2. Synopsis
Secondary 
Endpoints 
Clinical success rate in adolescents and 
young adults, defined as subjects ages 
13-21 years of age without re-
intervention at 6 and 12 months post-
operative 
4. Table of Contents
and throughout 
protocol 
Original sections and page numbers
Updated sections and page numbers 
5.1 Background
Non-absorbable, soft suture anchors 
have recently been introduced for use 
in arthroscopic soft tissue to bone 
reattachment. 
 
Suture anchors are continuously 
evolving to improve anchor strength 
and to facilitate arthroscopic 
procedures. 
Non-absorbable, soft suture anchors 
have recently been introduced for use in 
arthroscopic or open soft tissue to bone 
reattachment. 
 
Suture anchors are continuously evolving 
to improve anchor strength and to 
facilitate arthroscopic or open 
procedures. 
8.1.1 Indications 
Note: Foot, ankle, elbow, hand and 
wrist indications are not included in 
Note: Foot, ankle, elbow, hand and wrist 
indications are not included in the above 
list as data will not be collected.  As the 

 
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TMP-110  Clinical Protocol - Devices  
SOP-059 Clinical Protocols 
 
the above list as data will not be 
collected.   
study is collecting real world data 
retrospectively, data may be collected 
on the shoulder, knee, or hip beyond the 
indications listed above. 
9.1 Subject 
Population 
To eliminate the potential for bias, 
Investigators will consecutively screen 
subjects by date of surgery, starting 
with subjects that have undergone 
arthroscopic instability repair with Q-
Fix  All-Suture Anchor system in the 
past 12 months as of the IRB approval 
date. 
 
To eliminate the potential for bias, 
Investigators will consecutively screen 
subjects by date of surgery, starting with 
subjects that have undergone 
arthroscopic or open soft tissue repair 
with Q-Fix  All-Suture Anchor system in 
the past 12 months as of the IRB 
approval date, or using another date as 
agreed upon by the Investigators and 
site. In addition, to ensure enrollment of 
Q-Fix MINI subjects, a different 
enrollment start date may be selected to 
enroll Q-Fix MINI subjects only.    
9.2 Inclusion Criteria 1.  Subject has undergone 
arthroscopic or open soft tissue repair 
with Q-Fix  All-Suture Anchor System 
2. Subject was  
13 of age at time of 
surgery 
1.  Subject has undergone arthroscopic 
or open soft tissue repair with Q-Fix  
All-Suture Anchor System 
2. Subject was  
13 of age at time of 
surgery 
9.5 Informed 
Consent 
 
If the subject is an adolescent ages 13-17 
years old, a signed adolescent informed 
consent form will be required of the 

 
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Version: 2.0 05SEP2019 
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CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
SOP-059 Clinical Protocols 
 
subject as well as a signed parental 
informed consent form of a parent or 
guardian. 
10.1 Study Design
A minimum of 90 subjects and a 
maximum of 360 subjects in the 
United States who underwent surgery 
in the knee, shoulder or hip using the 
Q-Fix
All- Suture Anchor System are 
planned to be enrolled into the study 
after the fulfilment of all inclusion and 
exclusion criteria.  
A minimum of 90 subjects and a 
maximum of 450 subjects in the United 
States who underwent surgery in the 
knee, shoulder or hip using the Q-Fix
All- Suture Anchor System are planned to 
be enrolled into the study after the 
fulfilment of all inclusion and exclusion 
criteria. 
10.2.2 Secondary 
Endpoints 
Clinical success rate in adolescents and 
young adults, defined as subjects ages 13-
21 years of age without re-intervention at 
6 and 12 months post-operative 
10.3.3 Balanced 
Covariates 
The inclusion/exclusion criteria will be 
generalizable and applicable to the 
widest possible subset of the 
population suffering from arthroscopic 
instability. 
The inclusion/exclusion criteria will be 
generalizable and applicable to the 
widest possible subset of the population 
requiring arthroscopic or open surgery 
for soft tissue repair. 
12.2 Analysis 
Populations 
Safety Population (SAF): This includes 
all subjects who enroll in the study 
who had previously undergone 
arthroscopic repair using the Q-
Safety Population (SAF): This includes all 
subjects who enroll in the study who had 
previously undergone arthroscopic or 
open soft tissue repair using the Q-

 
Study Protocol
Device 
Safety and Performance of Q-
-Suture Anchor 
System 
Number: 17-5010-11
Version: 2.0 05SEP2019 
Page: Page 62 of 62 
 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
SOP-059 Clinical Protocols 
 
 
 
 
 
All-Suture Anchor System i.e. subjects 
who only provide retrospective data.  
All-Suture Anchor System i.e. subjects 
who only provide retrospective data.  
12.3.2 Analysis of 
Secondary 
Endpoint(s) 
Clinical success rate on adolescents and 
young adults, defined as subjects ages 
13-21 without re-intervention at 6 and 
12 months post-operative, as assessed 
by the surgeon. The same type of 
analysis carried out on the primary 
endpoint would be implemented here as 
well.