Safety and Performance of MINITAC◊ Ti 2.0 Suture Anchor in Extremities
Conditions: Hallux Valgus Repairs, Medial or Lateral Instability Repairs/Reconstructions, Achilles Tendon Repairs/Reconstructions, Midfoot Reconstructions, Metatarsal Ligament/Tendon Repairs/Reconstructions, Scapholunate Ligament Reconstructions, Ulnar or Radial Collateral Ligament Reconstructions, Lateral Epicondylitis Repair, Biceps Tendon Reattachment
Sponsor: Smith & Nephew, Inc.

Study Protocol—Device
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Sponsor Name and
Address:
Smith & Nephew Pty Ltd
85 Waterloo Road 
North Ryde
New South Wales, 2113
Australia
Investigational Product(s)
MINITAC Ti 2.0 Suture Anchor
Protocol Author(s):
Evita Höllige - Senior Clinical Study Manager
Babajide Olayinka - Senior Biostatistician

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SIGNATURES
1.1
PRINCIPAL INVESTIGATOR SIGNATURE PAGE
This page will be returned to Smith & Nephew and a copy retained at the investigational site.
I have read the attached protocol entitled “
Anchor in Extremities”, version 3.0, dated 20Aug19 and agree to abide by all provisions set forth 
herein.
I agree to comply with the Investigator’s Obligations stipulated in Section 21.4 of the protocol, 
I agree to ensure that the confidential information contained in this document will not be used for 
any purpose other than the conduct of the described clinical investigation without the prior written 
consent of Smith & Nephew.
Name, Address, 
Professional Position
Signature
Date Signed
(DD/MMM/YYYY)

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1.2
SPONSOR APPROVAL
Job title
DocuSign Stamp
Regional Operations 
Director signing on 
behalf of Head of Global 
Clinical Operations
Regional Operations 
Director signing on 
behalf of Senior 
Director
Regional Operations 
Director signing on 
behalf of Head of Global 
Clinical Strategy
Regional Operations 
Director signing on 
behalf of Vice 
President, Clinical 
Strategy
Head of Global 
Biostatistics
Director Biostatistics 
and Data Management

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SYNOPSIS
Title of Study:
Safety and Performance of MINITAC Ti 2.0 Suture Anchor in 
Extremities
Study Design:
A retrospective, multi-center, case series
Study Type:
Post-market, clinical follow-up study, non-interventional
Study Product: 
MINITAC Ti  2.0 Suture Anchor
Study Purpose:
Post-market clinical follow-up to support Notified Body (BSI) 
requirements for extremities repair indications.
Primary Objective:
Assess safety and performance of the MINITAC Ti  2.0 Suture Anchor
in extremities over a time period of 6 months after intervention.
Secondary Objective:
Assess safety and performance of the MINITAC Ti  2.0 Suture Anchor
in extremities over a time period of 12 months after intervention.
Sample Size:
The study sample was decided based on the feasibility of recruitment, 
enrollment and follow-up considerations. A minimum of 30 subjects
(minimum of 10 subjects per site) up to a maximum of 50 subjects will
be enrolled.
It is reasonable to estimate a clinical success rate of 95% for the 
MINITAC Ti 2.0 Suture Anchor in this study. As a result, the probability 
of estimating the 95% Confidence Interval for the clinical success of 
95% to be between 85% and 100% is between 55.4% and 98.8% for 
30 to 50 subjects.
Number of Study Sites:
Up to 3 sites
Targeted Global 
Regions:
Australia and EU (European Union)

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Inclusion Criteria:
1.
Subject has undergone extremities repair using the MINITAC
Ti 2.0 Suture Anchor.
2.
3.
Subject status is > 12 months post-operative.
Exclusion Criteria:
1.
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 approximately two years from 
first site initiation until final study report.
Primary endpoint:
Clinical success rate (%) of the MINITAC Ti  2.0 Suture Anchor in 
extremities at 6 months post-operative with clinical success defined as 
extremity repairs without signs of device failure and/or re-intervention 
as assessed by the surgeon.
Secondary endpoint(s):
Clinical success rate (%) of the MINITAC Ti  2.0 Suture Anchor in 
extremities at 12 months post-operative with clinical success defined 
as extremity repairs without signs of device failure and/or re-
intervention as assessed by the surgeon.
Other exploratory 
endpoint(s):
Surgeon Reported Outcomes based on data collected in the subject’s 
medical chart as standard of care at study sites. This may include but 
is not limited to the following:
Range of Motion (ROM)
Pain assessed by Visual Analogue Scale (VAS)
Listing of device failure criteria.
Safety Data
All adverse events (AEs) and complications occurring from the 
time of subject enrollment until study termination or study 
completion including intra-operative adverse events and 
complications.

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Device related re-interventions.
Device Deficiencies.
STUDY SCHEDULE
Schedule of Events 
Chart Review1
Screening 
6 months (182 days) 
post-op  
(+30/- 150 days)
12 months (365 days) 
post-op  
(+ 30/- 150 days)
Inclusion/Exclusion 
X 
 
Demographics/Medical History 
X 
 
Operative Data Collection 
X 
 
Assessment of clinical success 
(device related re-intervention 
and/or repair failure) 
X 
X 
Surgeon Reported Outcomes: 
Pain assessed by VAS2
X 
X 
X 
Surgeon Reported Outcomes: 
ROM2
X 
X 
X 
Concomitant Medications or 
Therapies 
X 
X 
X 
All Adverse Events or 
Complications, Device Deficiency 
(DD) 
X 
X 
X 
AE Assessment 
X 
X 
X 
End of Study 
X 
1 Given the retrospective study design, data will be collected to the extent it is available.
2 Surgeon Reported Outcomes are collected per standard of care. 

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CONTENTS
3.1
TABLE OF CONTENTS
 
Signatures..........................................................................................................................................2
1.1 
Principal Investigator Signature Page........................................................................................2
1.2 
Sponsor Approval ......................................................................................................................3
 
Synopsis.............................................................................................................................................4
 
Contents.............................................................................................................................................7
3.1 
Table of Contents.......................................................................................................................7
3.2 
List of Tables..............................................................................................................................9
3.3 
List of Figures.............................................................................................................................9
3.4 
List of Abbreviations And definitions........................................................................................10
 
Introduction ......................................................................................................................................12
4.1 
Background..............................................................................................................................12
4.2 
Literature Summary .................................................................................................................12
4.3 
Study Purpose .........................................................................................................................14
4.4 
Safety Considerations..............................................................................................................14
 
Objective(s) ......................................................................................................................................14
5.1 
Primary Objective.....................................................................................................................14
5.2 
Secondary Objective................................................................................................................14
 
Investigational Product(s).................................................................................................................14
6.1 
Identification.............................................................................................................................14
6.2
Product Use .............................................................................................................................16
6.3 
Packaging and Labeling...........................................................................................................16
6.4 
Product Accountability Procedures..........................................................................................16
6.5 
Surgical Technique ..................................................................................................................16
 
Subject Enrollment and Withdrawal.................................................................................................16
7.1 
Subject Population...................................................................................................................16
7.2 
Inclusion Criteria ......................................................................................................................16
7.3 
Exclusion Criteria.....................................................................................................................17
7.4 
Screening.................................................................................................................................17
7.5 
Informed Consent ....................................................................................................................17
7.6 
Enrollment................................................................................................................................19
7.7 
Lost to Follow-Up.....................................................................................................................20
7.8 
Withdrawal ...............................................................................................................................20

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Study Design....................................................................................................................................21
8.1 
Study Design............................................................................................................................21
8.2 
Study Endpoints.......................................................................................................................22
8.3 
Methods Used to Minimize Bias and Maximize Validity ..........................................................23
 
Study Procedures.............................................................................................................................24
9.1 
Visits and Examinations...........................................................................................................24
9.2 
Study Methods and Measurements.........................................................................................27
9.3 
Health Economics/Quality of Life.............................................................................................27
 
Statistical Design..............................................................................................................................27
10.1 
General ....................................................................................................................................28
10.2 
Analysis Populations................................................................................................................28
10.3 
Baseline Data...........................................................................................................................28
10.4 
Efficacy Analysis......................................................................................................................28
10.5 
Safety Analyses .......................................................................................................................29
10.6 
Interim Analyses ......................................................................................................................30
Sample Size Justification .................................................................................................................30
 
Adverse Events and Device Deficiencies ........................................................................................30
12.1
Definitions ................................................................................................................................30
12.2 
AE Coding Dictionary...............................................................................................................34
12.3
Reporting Procedures..............................................................................................................34
12.4 
Follow-up of Subjects with Adverse Events.............................................................................37
Investigator Obligations....................................................................................................................38
 
Sponsor and Monitor Responsibilities..............................................................................................38
14.1
Site Qualification Visit ..............................................................................................................38
14.2 
Site Initiation Visit.....................................................................................................................38
14.3
Sponsor Audits and Regulatory Inspection..............................................................................39
14.4 
Close-out Visit..........................................................................................................................39
Protocol Amendments......................................................................................................................39
 
Confidentiality of the Study ..............................................................................................................39
Statements of Compliance...............................................................................................................40
 
End of Study.....................................................................................................................................40
Publication Policy.............................................................................................................................40
19.1 
Publication of Study Data.........................................................................................................40
19.2
Data Sharing ............................................................................................................................41
 
References.......................................................................................................................................42

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Appendices ......................................................................................................................................44
21.1 
Protocol Amendment ...............................................................................................................44
21.2 
Instructions For Use.................................................................................................................48
21.3 
Investigational Product Description .........................................................................................48
21.4 
Principal Investigator Obligations (ISO14155:2011)................................................................49
3.2
LIST OF TABLES 
Table 9.1-1: Study Procedures by Visit....................................................................................................... 24 
Table 12.1-1: Categories of Adverse Event ................................................................................................ 31
3.3
LIST OF FIGURES
Figure 6.1-1: MINITAC Ti  2.0 Suture Anchor............................................................................................ 15 
Figure 8.1-1: Study Flowchart ..................................................................................................................... 21
Figure 12.3-1: Evaluation and Reporting of AE........................................................................................... 36 
Figure 12.3-2: Evaluation and Reporting of DD .......................................................................................... 37 

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3.4
LIST OF ABBREVIATIONS AND DEFINITIONS
Abbreviation
Definition
ADE
Adverse Device Effect(s)
AE
Adverse Event(s)
AFOAS
American Orthopaedic Foot & Ankle Society
ASADE
Anticipated Serious Adverse Device Effect(s)
BSI
British Standards Institute
CRF
Case Report Form(s)
CTA
Clinical Trial Agreement
CV
Curriculum Vitae
DD
Device Deficiency(ies)
EC
Ethics Committee
EU
European Union
GCP
Good Clinical Practice
HREC
Human Research Ethics Committee
ICMJE
International Committee of Medical Journal Editors
ID
Identification (ID) number
IFU
Instructions for Use
NA or N/A
Not Applicable
Non-
interventional 
study
A clinical study in which the investigational medical device of interest is used 
in accordance with the approved instructions for use. Assigning a 
subject/patient to a particular therapeutic arm is not decided in advance by a 
protocol but falls within current practice; use of the device is clearly separated 
from the decision to include the patient in the study. No additional diagnostic 
or monitoring procedures are used, and epidemiological methods are used to 
analyse the collected data.
PI
Principal Investigator
PP
Per-protocol Population
ROM
Range of Motion
S&N
Smith & Nephew Orthopaedics AG

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Abbreviation
Definition
SADE
Serious Adverse Device Effect(s)
SAE
Serious Adverse Event(s)
SAF
Safety population
SAP
Statistical Analysis Plan
UHMW
Ultra-high-molecular-weight
USADE
Unanticipated Serious Adverse Device Effect(s)
VAS
Visual Analogue Scale

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INTRODUCTION
4.1
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, non-steroidal anti-
inflammatory drugs, injection of steroids with lidocaine, and physical therapy. Several clinical 
studies were identified that reported higher clinical outcome scores (9, 19), or the ability to return 
to previous level of activity (6, 9), or lower complication/re-injury rate (1, 9) 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 (8, 10, 11, 18). 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 (5).
Suture anchors come in many diameters, lengths and materials, such as titanium, stainless steel, 
polyetheretherketone, or biodegradable absorbable materials such as polylactic acid and poly-L-
lactic acid.
4.2
LITERATURE SUMMARY
MINITAC Ti  2.0 Suture Anchors from Smith & Nephew are metallic suture anchors. Metallic 
(stainless steel or titanium alloy) implants provide rigid, reliable fixation and have been used 
successfully for decades (5). They provide excellent fixation but can be associated with loosening 
and migration, which may lead to cartilage damage. Metallic implants can present postoperative 

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distortion of repaired tissue during radiographic assessment (22). As cited by Suchenski et al, the 
majority of bone anchors currently approved for clinical use are made of metal (20).
The use of metallic suture anchors in foot and ankle was evaluated by Molloy et al. and Petrera 
et al. (13, 15). The two studies reported on a total of 67 joints, with a mean follow up of 25-42
months. Molloy et al. reported one patient (5.5%) who complained of scar tenderness, and the 
suture was excised at 9 months (13). Symptoms were resolved after 6 weeks. Mean American 
Orthopaedic Foot & Ankle Society (AFOAS) scores improved from 53 to 96, and eight patients 
resumed normal pre-injury activity levels. Petrera et al. reported 6% of patients experienced minor 
complications which included two cases of superficial wound infection (4%), which resolved after 
oral antibiotic treatment, and one case of temporary neuropraxia (2%) of the superficial peroneal 
nerve (15). AFOAS scores improved from an average of 36 preoperatively to an average of 75.4 
postoperatively. The pain subscale improved from 35 to 75, symptom subscale from 38 to 70, and 
QOL subscale from 35 to 75.
The use of metallic suture anchors in hand wrist and elbow was evaluated by Micic et al. and Iba 
et al. (7, 12). These publications reported on a total of 28 patients, with a mean follow up of 20.5 
to 51 months. Micic et al. reported 13 patients (65%) presented with heterotropic calcification of 
the joint capsule and collateral ligaments postoperatively (12). Post-traumatic degenerative 
change was found in six patients (30%). However, in most patients, this was not clinically 
significant. Concentric stability was achieved in all patients, and 18 patients (75%) had a firm 
endpoint during the valgus stress test. Overall mean functional motor evoked potentials was 93.2. 
Iba et al. reported no patients who demonstrated continuing symptoms, and all patients had a 
stable metacarpophalangeal joint after surgery (7). Postoperative grip strength and pinch strength 
were increased compared with preoperative values. All patients returned fully to their pre-injury 
work or sporting activities within six months after surgery. Postoperative flexion was decreased by 
an average of six degrees, but no patients noted functional deficiency.

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4.3
STUDY PURPOSE
This is a retrospective study to evaluate intra-operative, 6 months and 12 months safety and 
performance of the MINITAC Ti  2.0 Suture Anchors for extremities repair to meet post-market 
clinical follow-up requirements as outlined by the Notified Body (BSI).
4.4
SAFETY CONSIDERATIONS
The MINITAC Ti  2.0 Suture Anchor is intended to provide secure reattachment of soft tissue to 
bone in the foot and ankle as well as elbow, wrist and hand. Representative language of the 
contraindications and potential adverse effects from the MINITAC Ti  2.0 Suture Anchor can be 
found in the Instructions for Use (IFU). 
OBJECTIVE(S)
5.1
PRIMARY OBJECTIVE
The primary objective of this study is to assess safety and performance of the MINITAC Ti  2.0 
Suture Anchor in extremities over a time period of 6 months after intervention.
5.2
SECONDARY OBJECTIVE
The secondary objective of this study is to assess safety and performance of the MINITAC Ti  2.0 
Suture Anchor in extremities over a time period of 12 months after intervention.
INVESTIGATIONAL PRODUCT(S)
6.1
IDENTIFICATION 
6.1.1
Investigational Product
The MINITAC Ti  2.0 Suture Anchor is designed to provide secure reattachment of soft tissue to 
bone in extremities. It is available in 2.0mm size with double suture configuration.
Suture anchors are manufactured out of a titanium alloy whereas the sutures are either braided, 
silicone or polytetrafluoroethylene impregnated, polyester, non-absorbable or braided, uncoated, 
ultra-high-molecular-weight (UHMW) polyethylene and UHMW polyethylene with monofilament 

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polypropylene cobraid, non-absorbable. The Mini TAC™ 2.0 mm suture anchors are available 
either with stainless steel needles preassembled to the insertion device or without needles.
Figure 6.1-1: MINITAC Ti  2.0 Suture Anchor
MINITAC Ti  2.0 Suture Anchors are intended for use in the foot and ankle, as well as elbow, 
wrist and hand. MINITAC Ti  2.0 Suture Anchors are intended to be used for the following 
indications:
Foot and Ankle
o
Hallux valgus repairs
o
Medial or lateral instability repairs / reconstructions
o
Achilles tendon repairs / reconstructions
o
Midfoot reconstructions
o
Metatarsal ligament / tendon repairs / reconstructions
Elbow, Wrist, and Hand
o
Scapholunate ligament reconstructions
o
Ulnar or radial collateral ligament reconstructions
o
Lateral epicondylitis repair
o
Biceps tendon reattachment
Reference numbers for MINITAC Ti  2.0 Suture Anchors allowed in this study can be found in 
section 21.3.

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6.2
PRODUCT USE
Each device is packaged with an IFU (Document ID 10600149, Rev. C; 1061081, Rev E; 1061170,
Rev F and 10600403 Rev D) to ensure that the device is used properly and for the intended 
purposes.
6.3
PACKAGING AND LABELING
A commercial product is being used as approved for this study. Labeling is done as per the
standard commercial packaging.
6.4
PRODUCT ACCOUNTABILITY PROCEDURES
This is a post-market study and no product accountability procedures will be applied.
6.5
SURGICAL TECHNIQUE
The operative visit of this study is retrospective. The use of the MINITAC Ti  2.0 Suture Anchors
was performed per standard of care at the participating sites and in accordance with the IFU.
SUBJECT ENROLLMENT AND WITHDRAWAL
7.1
SUBJECT POPULATION
A minimum of 30 and a maximum of 50 subjects should be enrolled into the study at up to 3 sites. 
7.2
INCLUSION CRITERIA
Subjects will be considered qualified for enrollment if they meet the following criteria:
1.
Subject has undergone extremities repair using the MINITAC Ti  2.0 Suture Anchor.
2.
.
3.
Subject status is > 12 months post-operative.

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7.3
EXCLUSION CRITERIA
Any one (1) of the following criteria will disqualify a potential subject from participation in the study:
1.
Subject is entered in another investigational drug, biologic, or device study or has been 
treated with an investigational product within 12 months post-operative.
7.4
SCREENING 
Subject screening will include a retrospective chart review. To eliminate the potential for selection 
bias, Investigators will consecutively screen subjects that have undergone extremities repair using 
Suture Anchor by date of surgery, starting from the earliest surgery date, 
moving forward in time, up until dates of surgery which are at least 12 months prior to the study 
start date at each site.
Participating study sites are required to document all screened subjects considered for inclusion 
in this study on the Screening and Enrollment Log. If a subject is excluded from the study, the 
reasons for exclusion will be documented on the Screening and Enrollment Log.
7.5
INFORMED CONSENT
Study sites will obtain HREC/EC approval before any study specific activities are performed. The 
Investigator and the Participating Site shall treat all information and data relating to the Study 
disclosed to Participating Site and/or Investigator in this Study as confidential and shall not 
disclose such information to any third parties or use such information for any purpose other than 
the performance of the Study. The collection, processing and disclosure of personal data, such as 
patient health and medical information is subject to compliance with applicable personal data
protection and the processing of personal data (16,17, 24).
Due to the retrospective nature of the study, a HREC/EC waiver of informed consent for study 
participation should be requested for those subjects who meet eligibility criteria. If allowed, the
retrospective data set will be collected for these subjects. No prospective visits will be performed.
In Australia, a waiver or alteration of the requirements for obtaining informed consent may be 

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granted by the HREC/EC under any of the following provisions set forth by the National Statement 
on Ethical Conduct in Human Research published by National Health and Medical Research 
Council, Australia (14):
a) involvement in the research carries no more than low risk to participants
b) the benefits from the research justify any risks of harm associated with not seeking consent
c)
it is impracticable to obtain consent
d) there is no known or likely reason for thinking that participants would not have consented 
if they had been asked
e) there is sufficient protection of their privacy
f)
there is an adequate plan to protect the confidentiality of data
g) in case the results have significance for the participants’ welfare there is, where 
practicable, a plan for making information arising from the research available to them 
h) the possibility of commercial exploitation of derivatives of the data or tissue will not deprive 
the participants of any financial benefits to which they would be entitled
i)
the waiver is not prohibited by State, federal, or international law.
If an HREC/EC waiver is not granted, then the informed consent shall be obtained from all study
subjects according to ISO 14155:2011 guidelines and the latest version of the Helsinki Declaration
(3, 23). All applicable national regulations will also be followed including but not limited to the 
National Statement on Ethical Conduct in Human Research in Australia and in Belgium, the
Belgian law of 7 May 2004 related to experiments on Humans (2, 14). In this case, Informed 
consent will be obtained either by mail or over the phone. 
By mail: The potential subject will be sent the informed consent form and information sheet from 
a member of the study team. If the subject has any questions regarding their participation in the 
study, they can contact a member of the study team. If the subject is willing to participate, they 
sign and date the informed consent form and mail it back to the study team. The Investigator or 
designee will countersign the Informed Consent form. A copy of the signed informed consent 
documentation will be provided to the subject by mail, a copy will be placed in the subject’s medical 
record, with the original filed in the Investigator Site File.

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If the subject is unable to read, the informed consent document and associated study information 
may be read aloud to the subject in the presence of an impartial witness. If possible the subject 
shall sign and personally date the informed consent form. Where this is not possible, due to 
difficulties in writing, the subject shall provide verbal consent to participate in the study. The 
witness shall then personally sign and date the informed consent form, attesting that the 
information was accurately explained and that the informed consent was freely given. The 
informed consent process and documentation will be in accordance with all local regulations.
Over the phone: Upon receipt of the the informed consent form and information sheet by mail a
delegated member of the study team will contact the potential subject to inform the subject of the 
purpose of the study and the potential risks and benefits known. If the subject agrees to participate,
informed consent is documented by the study team member who obtained informed consent on 
the Telephone Informed Consent Log. In addition, the subject will be sent a letter of confirmation
of the phone conversation and study participation.
If a subject refuses participation, no further information will be collected. Reason for exclusion 
should be noted on the Screening and Enrollment Log.
7.6
ENROLLMENT
For screening, only information available in the medical records will be reviewed. Once a potential 
subject has been identified, all inclusion criteria and none of the exclusion criteria have been met 
and the informed consent process has been completed or a waiver of consent has been granted 
by the HREC/EC, the subject will be considered enrolled and assigned a consecutive Subject 
Identification (ID) number. Enrollment and assigned Subject ID will be documented on the 
Screening and Enrollment Log. For bilateral subjects, only one Subject ID will be assigned.
Any subject who provides informed consent or has a waiver of informed consent and is 
subsequently identified not meeting the required entry criteria is considered to be a screen failure. 
Demographic information must be captured in the appropriate CRF and the reason for screen 
failure will be documented on the Screening and Enrollment Log.

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7.7
LOST TO FOLLOW-UP
A subject will be considered lost to follow-up if he/she did not return for follow-up per the 
Investigator’s standard of care follow-up schedule. Information will be documented on the Case 
Report Form (CRF).
7.8
WITHDRAWAL
7.8.1
Withdrawal from Study
All reasonable efforts should be made to collect 12 months postoperative data on all subjects 
enrolled into the study. The Investigator may withdraw subjects from the study for many reasons, 
including but not limited to the following:
subject lost to follow-up
if the Investigator or the Sponsor stops the study for any reason and decides to withdraw 
subject(s) from the study
any other significant reason identified by the Investigator
For each case, information will be documented on the CRF, detailing circumstances leading to the 
withdrawal.
Subjects who drop out or are withdrawn will not be re-entered into the study at a later date.
7.8.2
Subject’s Withdrawal of Consent to Participate in Study
Study participation is voluntary, and subjects may withdraw at any point during the study without 
giving their reason for doing so. Where subjects withdraw consent, the Investigator should make 
a reasonable effort to ascertain the reason(s), while fully respecting the subject’s privacy. The 
reason for withdrawal will be recorded on the CRF.
7.8.3
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.

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STUDY DESIGN
8.1
STUDY DESIGN
This is a retrospective, multi-center, case series study to collect clinical data that will evaluate the 
safety and performance of the MINITAC Ti  2.0 Suture Anchor for indications in extremities. Up 
to 3 sites will participate in the study across Australia and the EU, collectively enrolling a minimum 
of 30 and a maximum of 50 subjects into the study. Each enrolling site will enroll a minimum of 10 
subjects.
Data from eligible subjects, who have completed the informed consent process as detailed in 
section 7.5 will be recorded from the subject medical file on designated CRFs. Data will be 
collected retrospectively for different time points including preoperative, operative, 6 months post-
operative and 12 months post-operative.
Figure 8.1-1 details the different steps of study conduct from screening to enrollment and follow-
up.
Figure 8.1-1: Study Flowchart

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8.2
STUDY ENDPOINTS
8.2.1
Primary Endpoint
Clinical success rate (%) of the MINITAC Ti  2.0 Suture Anchor in extremities at 6 months post-
operative with clinical success defined as extremity repairs without signs of device failure and/or 
re-intervention as assessed by the surgeon.
8.2.2
Secondary Endpoints
Clinical success rate (%) of the MINITAC Ti 2.0 Suture Anchor in extremities at 12 months post-
operative with clinical success defined as extremity repairs without signs of device failure and/or 
re-intervention as assessed by the surgeon.
8.2.3
Other Endpoints
Additional endpoints include surgeon reported outcomes as well as safety endpoints.
Surgeon reported outcomes include specific data collected as standard of care and documented 
in the medical records. This might include but is not limited to the following:
Range of Motion (ROM)
Pain assessed by Visual Analogue Scale (VAS)
Surgeon reported outcomes are optional and will be definitively specified in collaboration with the 
Investigators once sites have been identified for the conduct of the study.
In addition, a listing of device failure criteria will be collected for subjects that were assessed by 
the surgeon to have signs of device failure and/or re-intervention and therefore not meeting the 
definition of clinical success.
Safety endpoints include the collection of the following events from the subjects’ medical record:

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All adverse events (AEs) and complications occurring from the time of subject enrollment 
until study termination or study completion including intra-operative adverse events and 
complications.
Device related re-intervention.
Device Deficiencies.
8.3
METHODS USED TO MINIMIZE BIAS AND MAXIMIZE VALIDITY
8.3.1
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.
Consecutive enrollment will be performed starting at earliest surgeries moving forward in time.
8.3.2
Balanced Covariates
The inclusion/exclusion criteria will be generalizable and applicable to the widest possible subset 
of the population suffering from problems in the extremities. 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.
8.3.3
Subject Attrition
Subject attrition due to reduction in sample size required for precision analysis has been 
accounted in the sample size calculation so that the estimate of the Confidence Interval (CI) to be 
obtained will still be valid through the most efficient use of available subjects.
8.3.4
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 exploratory data 
analysis planned for the study which include construction of confidence intervals for the outcome 

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summaries and a pre-defined range in which the 95% CI for the primary outcome are expected to 
fall within are designed to maximize the validity of the study results.
More detailed specifications will be incorporated in the Statistical Analysis Plan (SAP) so as 
minimize any threats to external validity in order to yield clinically relevant estimates of effects and 
precision.
STUDY PROCEDURES
9.1
VISITS AND EXAMINATIONS 
9.1.1
Summary
For a summary of the required procedures by visit, refer to the Study Schematic .
Table 9.1-1.
Table 9.1-1: Study Procedures by Visit
Schedule of Events 
Chart Review1
Screening 
6 months (182 days) 
post-op  
(+30/- 150 days) 
12 months (365 days) 
post-op  
(+30/- 150 days) 
Inclusion/Exclusion 
X 
 
Demographics/Medical History
X
Operative Data Collection 
X 
 
Assessment of clinical success 
(device related re-intervention 
and/or repair failure) 
X 
X 
Surgeon Reported Outcomes:
Pain assessed by VAS2
X 
X 
X 
Surgeon Reported Outcomes:
ROM2
X 
X 
X 
Concomitant Medications or 
Therapies 
X 
X 
X 

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All Adverse Events or 
Complications, Device Deficiency 
(DD)
X 
X 
X 
AE Assessment 
X 
X 
X 
End of Study 
X 
1 Given the retrospective study design, data will be collected to the extent it is available.
2 Surgeon Reported Outcomes are collected per standard of care. 
9.1.2
Retrospective Chart Review - Screening
Given the retrospective study design, data will be collected from the medical chart to the extent it 
is available.
1.
Screen medical charts to identify subjects meeting the protocol inclusion/exclusion 
criteria as detailed in section 7.4 Screening.
2.
Obtain written informed consent from the identified subject or ensure HREC/EC approved 
waiver of consent was granted as detailed in section 7.5 Informed Consent.
----- Do not proceed until consent or waiver of consent has been obtained -----
3.
Assign the subject a Subject ID.
4.
Collect the following retrospective data, to the extent it is available, from the subject’s 
medical chart and complete the associated CRFs:
Obtain demographic information and medical history.
Obtain operative data including discharge.
Obtain surgeon reported outcomes as defined in section 8.2.3 to the extent 
available for the pre-operative time point.
Collect Adverse Events and Device Deficiencies from enrollment until discharge 
and intraoperative complications.
Collect concomitant medications or therapies.

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9.1.3
Retrospective chart review at 6 Months (182 days) Post-Operative (+ 30 days
/ - 150 days)
Given the retrospective study design, data will be collected from the medical chart to the extent it 
is available.
1.
Collect the following retrospective data, to the extent it is available, from the subject’s 
medical chart and complete the associated CRFs:
Review study implant status 6 months post-operative for device related re-
interventions and/or repair failure and assess clinical success.
Obtain surgeon reported outcomes as defined in section 8.2.3 to the extent 
available at the 6 months follow-up.
Collect Adverse Events and Device Deficiencies occurring from discharge until 6 
months follow-up.
Collect concomitant medications or therapies.
9.1.4
Retrospective chart review at 12 Months (365 days) Post-Operative (+ 30 days
/ -150)
Given the retrospective study design, data will be collected from the medical chart to the extent it 
is available.
1.
Collect the following retrospective data, to the extent it is available, from the subject’s 
medical chart and complete the associated CRFs:
Review study implant status 12 months post-operative for device related re-
interventions and/or repair failure and assess clinical success.
Obtain surgeon reported outcomes as defined in section 8.2.3 to the extent 
available at the 12 months follow-up.
Collect Adverse Events and Device Deficiencies occurring from 6 months until 12 
months follow-up.
Collect concomitant medications or therapies.

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9.1.5
Concomitant Medications and Therapies
Concomitant medications and concomitant therapies are recorded at any time from enrollment 
into the study through the subject’s last study visit. Concomitant medications should be recorded 
in the CRF providing the generic name.
9.1.6
Discontinued Subjects
Discontinued subjects are those who are withdrawn for reasons of safety or who are lost to follow-
up. Discontinued subjects should be documented on the Screening and Enrollment Log.
9.1.7
Subject Pregnancy
Due to the retrospective study design, subject pregnancy does not require specific considerations.
Data will be collected from the medical chart as documented by the treating physician.
9.2
STUDY METHODS AND MEASUREMENTS
Clinical success will be assessed by the surgeon at 6 months post-operative and at 12 months 
post-operative. Clinical success is defined as extremities repairs without signs of device failure 
and/or re-intervention as assessed by the surgeon. Used criteria for assessment of device failure 
and/or re-intervention will be provided by the surgeon on the designated CRF.
9.3
HEALTH ECONOMICS/QUALITY OF LIFE
Not applicable
STATISTICAL DESIGN
A SAP will be written and finalized prior to database lock. The SAP will contain more specific 
details of the statistical analyses that will be carried out as well as provide information on any 
changes or deviations from the projected analyses in this protocol. The Clinical Study Report will 
also highlight changes made to the analyses specified in the protocol.

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10.1
GENERAL
Smith & Nephew’s Global Biostatistics group 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. Point estimates and their corresponding 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).
10.2
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 repair using the 
.
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.
10.3
BASELINE DATA
Data to be summarized at baseline includes but is not limited to all collected demographic variable 
such as age, gender, primary diagnosis, height, weight, Body-Mass-Index and medical history. 
The baseline variables will be used to describe the outcome data where necessary. 
10.4
EFFICACY ANALYSIS
10.4.1 Analysis of Primary Endpoint
Clinical success rate at 6 months will be summarized using frequency (N) and percentage (%). A 
95% exact CI for a single proportion will be presented for clinical success at 6 months using the 
Clopper-Pearson method (1934) (4). This analysis will be carried out using the PP population as 
the primary analysis population with the SAF population used for sensitivity analysis.

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10.4.2 Analysis of Secondary Endpoint
Clinical success rate at 12 months will be summarized using frequency (N) and percentage (%). 
The same type of analysis described for the primary endpoint will be carried out on this secondary 
endpoint. This analysis will use the PP population as the primary analysis population and the SAF 
population for sensitivity analysis.
10.4.3 Analysis of Other Endpoints
Available data based on data collected from the subject’s medical chart as standard of care at 
study sites will be summarized and summary statistics tabulated.
o
The derivation of surgeon reported outcomes will be described in the SAP and will be 
summarized as appropriate using descriptive summary characteristics for continuous or 
categorical endpoints. Differences from screening/baseline to 6 months and 12 months will
be similarly summarized and/or compared. The details of distributional assumptions of the 
test statistics used will be described in the SAP.
10.5
SAFETY ANALYSES
All safety endpoints will be summarized using the safety population.
o
The incidence of events and types of events encountered on-study will be summarized as 
N (%). An overall AE table will summarize the information on subjects with at least one AE
as well as for AEs by the type of event.  A cumulative summary by the number of events 
encountered on all subjects overall and within each classification will additionally be 
included within tables summarized. 
o
A listing of subjects reporting device deficiencies will be provided.
o
A listing of device-related re-intervention will be provided.
o
A listing of concomitant medications will be provided by subject
Additional summaries of safety endpoints, if applicable, will be described in the SAP. 

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10.6
INTERIM ANALYSES
Not applicable.
SAMPLE SIZE JUSTIFICATION
This study is precision-based, as a result, the sample size is not based on statistical power 
calculations. 
It is reasonable to assume a success rate of 95% for the 
in this 
study. With a further assumption of a ± 10% precision in order to obtain a 95% CI of 85% to 100%, 
enrolling 30 subjects into the study will provide 55.4% probability. Across all investigational sites 
therefore, a minimum of 30 subjects (minimum of 10 subjects per site) up to a maximum of 50 
subjects overall (98.8% probability) across all sites will be enrolled into this study.
ADVERSE EVENTS AND DEVICE DEFICIENCIES
12.1
DEFINITIONS
The categories of adverse events are shown in Table 12.1-1. The definitions for each of these 
categories are given in the subsequent sections and are based on ISO 14155:2011 (3).

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Table 12.1-1: Categories of Adverse Event
NOT DEVICE-
RELATED
DEVICE- OR PROCEDURE-RELATED
NON-
SERIOUS
ADVERSE EVENT 
(AE)
ADVERSE DEVICE EFFECT 
(ADE)
SERIOUS
SERIOUS ADVERSE 
EVENT 
(SAE)
SERIOUS ADVERSE DEVICE EFFECT
(SADE) (SEE 12.1.3)
ANTICIPATED
UNANTICIPATED
ANTICIPATED SERIOUS 
ADVERSE DEVICE EFFECT 
(ASADE)
UNANTICIPATED SERIOUS 
ADVERSE DEVICE EFFECT  
(USADE)
12.1.1 Adverse Event
An Adverse Event (AE) is any untoward medical occurrence, unintended disease or injury, or
untoward clinical sign (including abnormal laboratory findings) in subjects, users or other persons, 
whether or not related to the IP.
Note 1: This definition includes events related to the IP, comparator or ancillary products. 
Note 2: This definition includes events related to the procedures involved. 
Note 3: For users or other persons, this definition is restricted to events related to the IP.
AE is used both to refer to AE which are non-serious non-IP or procedure-related and as an
umbrella term referring to adverse events of all classifications. 
An AE can be any unfavorable and unintended sign (for example, an abnormal laboratory finding), 
symptom, or disease. For reporting purposes, emphasis is placed first and foremost on whether 
or not the event constitutes an untoward medical occurrence.

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12.1.2 Adverse Device Effect
An Adverse Device Effect (ADE) is an adverse event related to the use of the IP.
Note 1: This definition includes adverse events resulting from insufficient or inadequate 
instructions for use, deployment, implantation, installation or operation, or any malfunction of the 
investigational medical device. 
Note 2: This definition includes any event resulting from use error or from intentional misuse of 
the investigational medical device. 
To differentiate between events that are related to the IP and events that are not related to the 
event the following notes should be taken into consideration:
Not Related: An AE is considered to be not related to the use of an IP or the procedure
when the effect is DEFINITELY UNRELATED or UNLIKELY to have any relationship to 
the use of the IP or the procedure;
Related: An AE is considered to be related to the use of an IP or the procedure when there 
is a POSSIBLE, PROBABLE, or DEFINITE relationship between the AE and the use of the 
IP or the procedure.
An ADE is further categorized depending on whether the criteria in section 12.1.3 and 12.1.4 are 
met.
12.1.3 Serious Adverse Events and Serious Adverse Device Effects
An AE or ADE is considered a Serious Adverse Event (SAE) or Serious Adverse Device Effect
(SADE) if, in the view of either the Investigator or the Sponsor, the event:
a) led to death,
b) led to serious deterioration in the health of the subject, that either resulted in
o
a life-threatening illness or injury, or
o
a permanent impairment of a body structure or a body function, or

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o
in-patient or prolonged hospitalization, or
o
medical or surgical intervention to prevent life-threatening illness or injury or 
permanent impairment to a body structure or a body function,
c)
led to foetal distress, foetal death or a congenital abnormality or birth defect
Note: Planned hospitalization for a pre-existing condition, or a procedure required by the study 
protocol, without serious deterioration in health, is not considered a serious adverse event.
12.1.4 Anticipated/Unanticipated Serious Adverse Device Effect
An Unanticipated Serious Adverse Device Effect (USADE) is a serious ADE which by its nature, 
incidence, severity or outcome has not been identified in the current version of the risk analysis 
report.
Note: Anticipated serious adverse device effect (ASADE) is an effect which by its nature, 
incidence, severity or outcome has been identified in the risk analysis report.
12.1.5 Severity 
The severity of every AE will be assessed by the PI or medically qualified site staff to whom the 
responsibility has been delegated and documented on the delegation of authority log. AE should 
be classified as mild, moderate, or severe, regardless of whether or not the AE are considered to 
be serious or non-serious. The classification should be based on the following definitions:
Mild
An event is mild if the subject is aware of, but can easily tolerate the sign or 
symptom;
Moderate
An event is moderate if the sign or symptom results in discomfort significant enough 
to cause interference with the subject’s usual activities;
Severe
An event is severe if the sign or symptom is incapacitating and results in the 
subject’s inability to work or engage in their usual activities.

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12.1.6 Device Deficiency
A Device Deficiency (DD) is an inadequacy of a medical device with respect to its identity, quality, 
durability, reliability, safety or performance. DD includes malfunctions, use errors and inadequate 
labeling.
12.2
AE CODING DICTIONARY 
The study will be coded using the internal Smith & Nephew coding dictionary titled Adverse Event 
Codes.
New version of Adverse Event Codes may be released over the course of the study and 
implemented. Any changes to the versions stated above will be captured in the Data Management 
Report.
12.3
REPORTING PROCEDURES
AE of any kind and DD will be identified from the source notes and recorded in the applicable 
CRF. The Investigator will evaluate all AE for relationship to the device and procedure, if 
applicable, seriousness, and severity. The following timescales should be followed for the AE/DD 
information to be entered into the CRF and reported to the Sponsor or designee (see Figure 12.3.1 
and Figure 12.3.2):
ADE and DD – without unreasonable delay
SAE, SADE and DD with potential to cause SADE – immediately (i.e. within 24 hours of 
the investigator being informed about the event)
For ADE and DD, details of the product/procedure related to the event will be included and where 
applicable, pictures taken of the device. The deficient product should be retained for return to 
S&N, if applicable, unless it is contaminated (e.g., used dressings must not be retained). Updates 
to submitted information will be recorded in the CRF according to the timescales above.
All adverse events 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. 

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The Investigator will inform the HREC/EC of adverse events according to the HREC/EC
requirements. 
Depending on the nature of the adverse event, the Sponsor may request copies of the subject’s 
medical records, imaging, operative notes, as well as results of any relevant laboratory tests 
performed or other documentation related to the AE. If the subject was hospitalized, a copy of the 
discharge summary may be requested by 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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Figure 12.3-1: Evaluation and Reporting of AE
Red path – accelerated reporting within 24 hours
Purple path – reporting without unreasonable delay
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
IMMEDIATELY  
Record 
information in 
patient CRF 
according to 
usual 
timescales.
Complete CRF 
and alert S&N
without 
unreasonable 
delay.
Record 
details in 
subject’s
medical 
records

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Figure 12.3-2: Evaluation and Reporting of DD
Red path – accelerated reporting within 24 hours
12.4
FOLLOW-UP OF SUBJECTS WITH ADVERSE EVENTS
Unresolved AEs should be followed by the Investigator until the events are resolved. For subjects 
who are experiencing ongoing unresolved AE at the time of their study completion or early 
discontinuation from the study, the Investigator will monitor these events as part of the site’s 
normal standard of care. Any additional data collected after study completion and related to an 
unresolved AE must be documented and made available to the Sponsor who will determine 
whether the data need to be documented on a CRF or in the Clinical Study Report.
12.4.1 Ongoing Adverse Events at Study Discontinuation
Adverse events which are related to a study procedure or IP and are ongoing at the end of 
subject’s participation: The event should be followed until it is either resolved or until the event 
has become chronic and is not expected to further improve based on Investigator’s review of the 
event.
Adverse events which are not related to a study procedure or IP and are ongoing at the end of 
subject’s participation should be followed for 30 days after discontinuation or if the AE is resolved,
whichever is sooner.
Site aware 
of DD
Investigator 
assesses whether 
could have led to 
SADE
Potential to cause SADE
No potential to cause SADE
Complete CRF and alert S&N
IMMEDIATELY  
Record information in patient 
CRF according to usual 
timescales.
Record details in subject’s
medical records

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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 will comply with the principles of Good Clinical Practice (GCP) as 
defined in ISO 14155:2011, and all applicable regulatory requirements as outlined in Appendix 
21.4 of this protocol.
In addition, the PI will ensure that the Financial Disclosure Statements will be completed by the PI 
and the Sub-Investigator upon entry into the study and as any changes that affect their financial 
disclosure status occur during the course of the study and up to one year after study completion.
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 and 
amendment(s), if applicable, with GCP regulations, and with applicable regulatory requirements.
Detailed monitoring requirements will be documented in the Clinical Monitoring Plan for this study. 
14.1
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.
14.2
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 

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the Sponsor following the execution of the Clinical Trial Agreement (CTA) and documented 
HREC/EC approval.
14.3
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. 
14.4
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 HREC/EC reporting requirements. 
A remote close-out visit may be considered under when no subjects have been enrolled at a study 
site due to different reasons.
PROTOCOL AMENDMENTS
Amendments should be made only in necessary cases once the study has started. Protocol 
amendments must be approved by the protocol signatories prior to submission to the HREC/EC.
Protocol amendments need to be approved by the HREC/EC 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.

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STATEMENTS OF COMPLIANCE
This clinical study will be performed in compliance with the ethical principles of the Declaration of 
Helsinki; and ISO 14155:2011 Clinical investigation of medical devices – Good Clinical Practice
(3,23).
This clinical study will not commence until the required approval/favorable opinion from the 
HREC/EC or regulatory authority, as applicable, has been obtained. Any additional requirements 
imposed by the HREC/EC or regulatory authority will be followed. 
END OF STUDY
Due to the retrospective design of the study, end of the study is defined as the date when the last 
subject is documented on CRFs.
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 of the Sponsor. 
PUBLICATION POLICY
19.1
PUBLICATION OF STUDY DATA
The preparation and submission for publication of manuscripts containing the study results shall 
be in accordance with a process determined by the Clinical Trial Agreements between the study 
Sponsor and participating institutions. The publication or presentation of any study results shall 
comply with all applicable privacy laws, including, but not limited to the latest version of the Privacy 
Act 1988, Australia (16), and the European and Belgian legislation on the protection of natural 
persons with regard to the processing of personal data (17, 24).

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19.2
DATA SHARING
Smith & Nephew is committed to upholding the highest ethical and legal standards involved in 
conducting clinical trials. Smith & Nephew, therefore, supports the data sharing requirements of 
The International Committee of Medical Journal Editors (ICMJE) published on the 6th June 2017
(21). In accordance, Smith & Nephew will consider requests to share individual (de-identified) 
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 nine 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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REFERENCES
1.
Arciero RA, Wheeler JH, Ryan JB, McBride JT. Arthroscopic Bankart repair versus 
nonoperative treatment for acute, initial anterior shoulder dislocations. Am J Sports Med. 
1994;22(5):589-94.
2.
Belgian Law related to experiments on humans (7 May 2004)
3.
Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 
14155:2011), (2011).
4.
Clopper CJ, Pearson ES. The Use of Confidence or Fiducial Limits Illustrated in the Case 
of the Binomial. Biometrika. 1934;26(4):404-13.
5.
Efird C, Traub S, Baldini T, Rioux-Forker D, Spalazzi JP, Davisson T, et al. Knotless single-
row rotator cuff repair: a comparative biomechanical study of 2 knotless suture anchors. 
Orthopedics. 2013;36(8):e1033-7.
6.
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 Surg Sports Traumatol Arthrosc. 2000;8(2):76-82.
7.
Iba K, Wada T, Hiraiwa T, Kanaya K, Oki G, Yamashita T. Reconstruction of chronic thumb 
metacarpophalangeal joint radial collateral ligament injuries with a half-slip of the abductor 
pollicis brevis tendon. J Hand Surg Am. 2013;38(10):1945-50.
8.
Kerin C, Hopgood P, Banks AJ. Delayed repair of the quadriceps using the Mitek anchor 
system: a case report and review of the literature. Knee. 2006;13(2):161-3.
9.
Kim SH, Oh JH, Lee OS, Lee HR, Hargens AR. Postoperative imaging of bioabsorbable 
anchors in rotator cuff repair. Am J Sports Med. 2014;42(3):552-7.
10.
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. Am J Sports 
Med. 2004;32(2):406-10.
11.
Maniscalco P, Bertone C, Rivera F, Bocchi L. A new method of repair for quadriceps 
tendon ruptures. A case report. Panminerva Med. 2000;42(3):223-5.
12.
Micic I, Kim SY, Park IH, Kim PT, Jeon IH. Surgical management of unstable elbow 
dislocation without intra-articular fracture. Int Orthop. 2009;33(4):1141-7.

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13.
Molloy AP, Ajis A, Kazi H. The modified Brostrom-Gould procedure--early results using a 
newly described surgical technique. Foot Ankle Surg. 2014;20(3):224-8.
14.
National Statement on Ethical Conduct in Human Research 2007 (Updated 2018), 
(2018).
15.
Petrera M, Dwyer T, Theodoropoulos JS, Ogilvie-Harris DJ. Short- to Medium-term 
Outcomes After a Modified Brostrom Repair for Lateral Ankle Instability With Immediate 
Postoperative Weightbearing. Am J Sports Med. 2014;42(7):1542-8.
16.
Privacy Act 1988, Compilation No. 77, (2018).
17.
Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 
on the protection of natural persons with regard to the processing of personal data and on 
the free movement of such data, and repealing Directive 95/46/EC (General Data 
Protection Regulation)
18.
Richards DP, Barber FA. Repair of quadriceps tendon ruptures using suture anchors. 
Arthroscopy. 2002;18(5):556-9.
19.
Smidt N, van der Windt DA, Assendelft WJ, Deville WL, Korthals-de Bos IB, Bouter LM. 
Corticosteroid injections, physiotherapy, or a wait-and-see policy for lateral epicondylitis: 
a randomised controlled trial. Lancet. 2002;359(9307):657-62.
20.
Suchenski M, McCarthy MB, Chowaniec D, Hansen D, McKinnon W, Apostolakos J, et al. 
Material properties and composition of soft-tissue fixation. Arthroscopy. 2010;26(6):821-
31.
21.
Taichman DB, Sahni P, Pinborg A, Peiperl L, Laine C, James A, et al. Data Sharing 
Statements for Clinical Trials: A Requirement of the International Committee of Medical 
Journal Editors. Ethiop J Health Sci. 2017;27(4):315-8.
22.
Woodmass JM, Matthewson G, Ono Y, Bois AJ, Boorman RS, Lo IK, et al. Suture locking 
of isolated internal locking knotless suture anchors is not affected by bone quality. Open 
Access J Sports Med. 2015;6:201-8.
23.
World Medical Association. World Medical Association Declaration of Helsinki: ethical 
principles for medical research involving human subjects. JAMA. 2013;310(20):2191-4
24.
Belgian Law: Law on the protection of natural persons with regard to the processing of 
personal data) (30 July 2018)

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APPENDICES
21.1
PROTOCOL AMENDMENT 
Section
Current Text 10 JAN 2019 
Version 2.0
Revised Text 20 AUG 2019 
Version 3.0
2.
Synopsis 
6 months (182 days) post-op
(+/- 90 days)
12 months (365 days) post-op
(+/- 90 days)
6 months (182 days) post-op
(+30/- 150 days)
12 months (365 days) post-op
(+ 30/- 150 days)
2.
Synopsis
3. Subjects who have undergone 
a device related re-intervention or 
were assessed as device failure 
will be considered terminated 
from the date of re-
intervention/failure.
3.4 Table of 
Abbreviations
EC
Ethics Committee
EU
European Union
6.1.1
The Mini TAC™ 2.0 mm suture 
anchors are available either with 
stainless steel needles 
preassembled to the insertion device 
or without needles.
6.2
Each device is packaged with an 
IFU (Document ID 10600149, 
Rev. C) to ensure that the device 
is used properly and for the 
intended purposes.
Each device is packaged with an IFU 
(Document ID 10600149, Rev. C; 
1061081, Rev E; 1061170, Rev F 
and 10600403 Rev D) to ensure that 
the device is used properly and for 
the intended purposes.
7.4
Subject screening will include a 
retrospective chart review. To 
eliminate the potential for 
selection bias, Investigators will 
consecutively screen subjects that 
have undergone extremities repair 
Anchor by date of surgery, 
starting by the date one year prior 
to the Human Research Ethics 
Committee (HREC) approval date 
Subject screening will include a 
retrospective chart review. To 
eliminate the potential for selection 
bias, Investigators will consecutively 
screen subjects that have undergone 
extremities repair using the 
date of surgery, starting from the 
earliest surgery date, moving forward 
in time, up until dates of surgery 

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going backwards in time. 
Screening will stop once the full 
enrollment number is reached.
which are at least 12 months prior to 
the study start date at each site.
7.5
The Investigator and the Participating 
Site shall treat all information and 
data relating to the Study disclosed 
to Participating Site and/or 
Investigator in this Study as 
confidential and shall not disclose 
such information to any third parties 
or use such information for any 
purpose other than the performance 
of the Study. The collection, 
processing and disclosure of 
personal data, such as patient health 
and medical information is subject to 
compliance with applicable personal 
data protection and the processing of 
personal data (16,17, 24).
7.5
If an HREC waiver is not granted, 
then the informed consent shall 
be obtained from all study
subjects according to ISO 
14155:2011 guidelines, the 
National Statement on Ethical 
Conduct in Human Research and 
all applicable national regulations 
(1, 19).
Potential subjects must be 
informed as to the purpose of the 
study and the potential risks and 
benefits known. The subject, or 
their legally authorized 
representative, will then read, 
sign, and personally date the 
HREC-approved informed 
consent document(s) (see below 
for difficulties with reading and 
writing). Additionally, the 
individual who obtains consent 
from the subject will sign and date 
the informed consent document. 
A copy of the signed informed 
consent documentation will be 
provided to the subject, a copy 
If an HREC/EC waiver is not granted, 
then the informed consent shall be 
obtained from all study subjects 
according to ISO 14155:2011 
guidelines and the latest version of 
the Helsinki Declaration (3, 23). All 
applicable national regulations will 
also be followed including but not 
limited to the National Statement on 
Ethical Conduct in Human Research 
in Australia and in Belgium, the 
Belgian law of 7 May 2004 related to 
experiments on Humans (2, 14). In 
this case, Informed consent will be 
obtained either by mail or over the 
phone.
By mail: The potential subject will be 
sent the informed consent form and 
information sheet from a member of 
the study team. If the subject has any 
questions regarding their 
participation in the study, they can 
contact a member of the study team. 
If the subject is willing to participate, 
they sign and date the informed 
consent form and mail it back to the 

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will be placed in the subject’s 
medical record, with the original 
filed in the Investigator Site File.
If the subject is unable to read, 
the informed consent document 
and associated study information 
may be read aloud to the subject 
in the presence of an impartial 
witness. If possible the subject 
shall sign and personally date the 
Informed Consent Form. Where 
this is not possible, due to 
difficulties in writing, the subject 
shall provide verbal consent to 
participate in the study. The 
witness shall then personally sign 
and date the informed consent 
form, attesting that the information 
was accurately explained and that 
the informed consent was freely 
given.
study team. The Investigator or 
designee will countersign the 
Informed Consent form. A copy of 
the signed informed consent 
documentation will be provided to the 
subject by mail, a copy will be placed 
in the subject’s medical record, with 
the original filed in the Investigator 
Site File. 
If the subject is unable to read, the
informed consent document and 
associated study information may be 
read aloud to the subject in the 
presence of an impartial witness. If 
possible the subject shall sign and 
personally date the informed consent 
form. Where this is not possible, due 
to difficulties in writing, the subject 
shall provide verbal consent to 
participate in the study. The witness 
shall then personally sign and date 
the informed consent form, attesting 
that the information was accurately 
explained and that the informed 
consent was freely given. The 
informed consent process and 
documentation will be in accordance 
with all local regulations.
Over the phone: Upon receipt of the 
the informed consent form and 
information sheet by mail a 
delegated member of the study team 
will contact the potential subject to 
inform the subject of the purpose of 
the study and the potential risks and 
benefits known. If the subject agrees 
to participate, informed consent is 
documented by the study team 
member who obtained informed 
consent on the Telephone Informed 
Consent Log. In addition, the subject 
will be sent a letter of confirmation of 
the phone conversation and study 
participation.

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Figure 8.1.1
Waiver of Informed Consent 
granted by HREC or written
subject consent received
Waiver of Informed Consent granted 
by HREC or subject consent 
received 
8.3.1
To minimize any potential for 
selection bias consecutive 
enrollment will be utilized to 
retrospectively enroll any subjects 
encountered that meet the 
inclusion/exclusion criteria. 
Consecutive enrollment will be 
performed starting at latest 
surgeries moving backwards in 
time.
To minimize any potential for 
selection bias consecutive enrollment 
will be utilized to retrospectively 
enroll any subjects encountered that 
meet the inclusion/exclusion criteria. 
Consecutive enrollment will be 
performed starting at earliest 
surgeries moving forward in time.
Table 9.1.1
6 months (182 days) post-op
(+/- 90 days) 
12 months (365 days) post-op
(+/- 90 days)
6 months (182 days) post-op
(+30/- 150 days) 
12 months (365 days) post-op
(+ 30/- 150 days)
Table 9.1.1
3. Subjects who have undergone 
a device related re-intervention or 
were assessed as device failure 
will be considered terminated 
from the date of re-
intervention/failure.
12.1.2
An Adverse Device Effect (ADE) 
is an adverse event that, in the 
opinion of the investigator, is 
related to the use of the IP.
An Adverse Device Effect (ADE) is 
an adverse event related to the use 
of the IP.
19.1.1
The publication or presentation of
any study results shall comply 
with all applicable privacy laws, 
including, but not limited to the 
latest version of the Privacy Act 
1988, Australia (2).
The publication or presentation of 
any study results shall comply with 
all applicable privacy laws, including, 
but not limited to the latest version of 
the Privacy Act 1988, Australia (16), 
and the European and Belgian 
legislation on the protection of 
natural persons with regard to the 
processing of personal data (17, 24).
21.2
2.0 Suture 
Anchor IFU 10600149 Rev. C.
10600149 Rev. C. (#72200795)
1061081, Rev. E. (# 7210295)
1061170 Rev. F. (# 7210303)

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2.0 Suture Anchor IFU 
10600403 Rev. D. (# 72202019)
21.3
Ti 2.0 preloaded with two #3-0
# 72200795 2.0mm MINITAC Ti 
Preloaded Suture Anchor with 2 
Durabraid sutures size 3-0
# 7210295 2.0mm MINITAC Ti
Suture Anchor with 2 Durabraid 
sutures     
# 7210303 2.0mm MINITAC Ti 
Preloaded Suture Anchor with 2 
Durabraid sutures size 3.0 and 
needles
# 72202019 2.0mm MINITAC Ti 
Suture Anchor with 2 Ultrabraid 
sutures size 2.0 and needles
All
Targeted region: Australian sites 
only
Targeted region: Australia and EU 
(European Union)
All
HREC
HREC/EC
All 
References updated throughout
21.2
INSTRUCTIONS FOR USE
Refer to:
hor IFU 10600149 Rev. C. (#72200795)
IFU 1061081, Rev. E. (# 7210295)
IFU 1061170 Rev. F. (# 7210303)
IFU 10600403 Rev. D. (# 72202019)
21.3
INVESTIGATIONAL PRODUCT DESCRIPTION
The following list specifies the investigational product reference number allowed within this 
study:
# 72200795 2.0mm MINITAC Ti Preloaded Suture Anchor with 2 Durabraid sutures size 3-0

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# 7210295 2.0mm MINITAC Ti Suture Anchor with 2 Durabraid sutures
# 7210303 2.0mm MINITAC Ti Preloaded Suture Anchor with 2 Durabraid sutures size 3.0 and 
needles
# 72202019 2.0mm MINITAC Ti Suture Anchor with 2 Ultrabraid sutures size 2.0 and needles 
21.4
PRINCIPAL INVESTIGATOR OBLIGATIONS (ISO14155:2011)
1.
General: 
a.
The role of the PI is to implement and manage the day-to-day conduct of the clinical 
investigation as well as ensure data integrity and the rights, safety, and well-being of the 
subjects involved in the clinical investigation. 
2.
Qualification of the PI. The PI shall:
a.
be qualified by education, training, and experience to assume responsibility for the proper 
conduct of the clinical investigation in accordance with this International Standard; 
evidence of such qualifications of the PI and key members of the investigation site team 
shall be provided to the Sponsor through up-to-date Curriculum Vitae (CV) or other 
relevant documentation,
b.
be experienced in the field of application and trained in the use of the investigational 
device under consideration,
c.
disclose potential conflicts of interest, including financial, that interfere with the conduct 
of the clinical investigation or interpretation of results, and
d.
be knowledgeable with the method of obtaining informed consent.
3.
Qualification of investigation site. The PI shall be able to demonstrate that the proposed 
investigation site:
a.
has the required number of eligible subjects needed within the agreed recruitment period, 
and
b.
has one or more qualified investigators, a qualified investigation site team and adequate 
facilities for the foreseen duration of the clinical investigation.
4.
Communication with the IEC. The PI shall: 

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a.
provide the Sponsor with copies of any clinical-investigation-related communications 
between the PI and the IEC,
b.
comply with the requirements described in 4.5 of ISO 14155:2011.
i.
Submit to the IEC the following information, any amendments and any additional 
documentation required by the IEC: the Protocol; IB or equivalent; informed 
consent form and any other written information provided to subjects; procedures for 
recruiting subjects and advertising materials, if any; a copy of the CV of the PI(s) 
for with the IEC has oversight.
ii.
Provide documentation of the IECs approval/favorable opinion, identifying the 
documents and amendments on which the opinion was based, to the Sponsor, prior
to commencing the clinical investigation. 
iii.
Submit the following to the IEC if required by national regulations, the protocol or 
IEC, whichever is more stringent:
1.
SAEs
2.
Requests for deviations, and reports of deviations, if the deviation affects 
subject’s rights, safety, and well-being, or the scientific integrity of the clinical 
investigation. Document and report to the Sponsor and IEC a report of 
deviations made to protect the rights, safety, and well-being of human subjects 
under emergency circumstances. 
3.
Progress reports, including safety summary and deviations
4.
Amendments to any documents already approved by the IEC. 
5.
If applicable, notifications of suspension or premature termination
6.
If applicable, justification and request for resuming the clinical investigation 
after suspension. 
7.
Clinical investigation report or summary.
iv.
As a minimum, during the clinical investigation, the following information shall be 
obtained in writing from the IEC prior to implementation:
1.
Approval/favorable opinion of amendments
2.
Approval of the request for deviations that can affect the subject’s rights, safety,
and well-being or scientific integrity of the clinical investigation
3.
Approval for resumption of a suspended clinical investigation if applicable. 

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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)
b.
Process of obtaining informed consent. The general process for obtaining informed 
consent shall be documented in the protocol and shall comply with the following. These 
requirements also apply with respect to informed consent obtained from a subject’s 
legally authorized representative: 
i.
Ensure that the PI or his/her authorized designee conducts the informed consent 
process
ii.
Include all aspects of the clinical investigation that are relevant to the subject’s 
decision to participate throughout the clinical investigation
iii.
Avoid any coercion or undue improper influence on, or inducement of, the subject 
to participate
iv.
Not waive or appear to waive the subject’s legal rights
v.
Use native non-technical language that is understandable to the subject
vi.
Provide ample time for the subject to read and understand the informed consent 
form and to consider participation in the clinical investigation

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vii.
Include personally dated signatures and the PI or an authorized designee 
responsible for conducting the informed consent process
viii.
Show how informed consent will be obtained in special circumstances (see below) 
where the subject is unable to provide him or herself, and 
ix.
Ensure important new information is provided to new and existing subjects 
throughout the clinical investigation. 
c.
Special circumstances for informed consent (the following provisions are subject to 
national regulations):
i.
Subject needing legally authorized representatives:  informed consent may be 
given by the legally authorized representative only if a subject is unable to make 
the decision to participate in a clinical investigation (e.g., infant, child, or juvenile,
seriously ill or unconscious subject, mentally ill person, mentally handicapped 
person). In such cases, the subject shall also be informed about the clinical 
investigation within his/her ability to understand. 
ii.
Subject unable to read or write: informed consent shall be obtained through a 
supervised oral process if a subject or legally authorized representative is unable 
to read or write. An independent witness shall be present throughout the process.
The written informed consent form and any other information shall be read aloud 
and explained to the prospective subject or his/her legally authorized representative 
and, whenever possible, either shall sign and personally date the informed consent 
form. The witness also signs and personally dates the informed consent for 
attesting that the information was accurately explained and that the informed 
consent was freely given. 
iii.
Emergency treatments: 
1.
For clinical investigations involving emergency treatments, when prior informed 
consent of the subject is not possible because of the subject’s medical 
condition, the informed consent of the subject’s legally authorized 
representative, if present, shall be requested. 
2.
When it is not possible to obtain prior informed consent from the subject, and 
the subject’s legally authorized representative, is not available, the subject may 
still be enrolled if a specific process has been described in the protocol. 

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3.
Arrangements shall be made to inform the subject or legally authorized 
representative, as soon as possible, about the subject’s inclusion in the clinical 
investigation and about all aspects of the clinical investigation. 
4.
The subject shall be asked to provide informed consent for continued 
participation as soon as his/her medical condition allows. 
d.
The Principal Investigator may not enroll a subject without obtaining informed consent of 
the subject or his/her legally authorized representative only when the following conditions 
are fulfilled: the prospective subject fulfils the emergency conditions and is obviously in a 
life-threatening situation; no sufficient clinical benefits are anticipated from the currently 
available treatment; there is a fair possibility that the life-threatening risk to the 
prospective subject can be avoided if the investigational device is used; anticipated risks 
are outweighed by the potential benefits of applying the investigational device ; the legally 
authorized representative cannot be promptly reached and informed. 
e.
Information provided to the subject. All information pertinent to the clinical investigation, 
including at least the following, shall be provided in writing and in native, non-technical 
language that is understandable to the subject (or the subject’s legally authorized
representative):
i.
Description and purpose
ii.
Potential benefits
iii.
Risks and inconveniences or the subject and, when applicable, for any embryo, 
fetus 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’s representative in the clinical investigation
ix.
Contact persons
x.
Statement declaring that new findings or the reasons for any amendment to the 
protocol that affect the subject’s continued participation shall be made available to 
the subject. 

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xi.
Statement indicating that, upon the subject’s approval, the subject’s personal 
physician will be informed of the subject’s participation in the clinical investigation
xii.
Termination procedures
f.
Informed consent signature shall contain the following: 
i.
The voluntary agreement to participate in the clinical investigation and follow the 
investigator’s instructions
ii.
A statement declaring that refusal of participation incurs no penalty for the subject
iii.
A statement declaring that discontinuation at any time incurs no penalty for the 
subject
iv.
A statement with regard to the possible consequences of withdrawal
v.
An acknowledgment of the information provided and confirmation that all the 
subject’s questions were answered
vi.
A statement confirming that the subject or his/her legally authorized representative 
agrees to the use of the subject’s relevant personal data for the purpose of the 
clinical investigation
vii.
A statement confirming that the subject or his/her legally authorized representative 
agrees 
that 
Sponsor’s 
representatives, 
regulatory 
authorities 
and 
IEC
representatives will be granted direct access to the subject’s medical records. 
g.
New information: if new information becomes available that can significantly affect a 
subject’s future health and medical care, that information shall be provided to the 
subject(s) affected in written form. If relevant, all affected subjects shall be asked to 
confirm their continuing consent in writing. 
h.
ensure compliance with the applicable regulatory requirements and ethical principles for 
the process of obtaining informed consent, and
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,

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d.
ensure that the investigational device is used solely by authorized users as specified in 
6.2, and in accordance with the protocol and instructions for use,
e.
propose to the Sponsor any appropriate modification(s) of the protocol or investigational 
device or of the use of the investigational device,
f.
refrain from implementing any modifications to the protocol without agreement from the 
Sponsor, IEC and regulatory authorities, if required,
g.
document and explain any deviation from the approved protocol that occurred during the 
course of the clinical investigation,
h.
ensure that an adequate investigation site team and facilities exist and are maintained 
and documented during the clinical investigation,
i.
ensure that maintenance and calibration of the equipment relevant for the assessment of 
the clinical investigation is appropriately performed and documented, where applicable,
j.
ensure the accuracy, completeness, legibility, and timeliness of the data reported to the 
Sponsor in the CRF and in all required reports,
k.
maintain the device accountability records,
l.
allow and support the Sponsor to perform monitoring and auditing activities,
m.
be accessible to the monitor and respond to questions during monitoring visits,
n.
allow and support regulatory authorities and the IEC when performing auditing activities,
o.
ensure that all clinical-investigation-related records are retained as required taking 
measures to prevent accidental or premature destruction, and
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 

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treatment, including decoding procedures for blinded/masked clinical investigations, as 
needed,
f.
ensure that clinical records are clearly marked to indicate that the subject is enrolled in a 
particular clinical investigation,
g.
if appropriate, subjects enrolled in the clinical investigation shall be provided with some 
means of showing their participation in the clinical investigation, together with 
identification and compliance information for concomitant treatment measures (contact 
address and telephone numbers shall be provided),
h.
inform, with the subject's approval or when required by national regulations, the subject's 
personal physician about the subject's participation in the clinical investigation, and 
i.
make all reasonable efforts to ascertain the reason(s) for a subject's premature 
withdrawal from the clinical investigation while fully respecting the subject's rights.
8.
Safety reporting. The Principal Investigator shall:
a.
record every adverse event and observed device deficiency, together with an 
assessment,
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.
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.