Efficacy of the BioWick SureLock Implant for the Reattachment of Soft Tissue to Bone in Subjects Undergoing Rotator Cuff Repairs
Phase: NA
Conditions: Rotator Cuff Tear
Sponsor: Zimmer Biomet

Study Protocol
Efficacy of the BioWick® SureLock® Implant for the 
Reattachment of Soft Tissue to Bone in Subjects             
Undergoing Rotator Cuff Repairs 
June 22, 2020
NCT03199391

BioWick® SureLock® Implant 
Protocol No.  CAY-001 
Confidential and Proprietary 
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CAYENNE MEDICAL, INC., A ZIMMER BIOMET COMPANY 
CLINICAL RESEARCH PROTOCOL 
Efficacy of the BioWick® SureLock® Implant for the Reattachment of Soft Tissue to 
Bone in Subjects Undergoing Rotator Cuff Repairs 
PROTOCOL NUMBER: CAY-001 
Date of Original Protocol: 
09/19/2016 
Version No.: 
2.3 
Principal Investigator: 
Multicenter 
Sponsor: 
Cayenne Medical, Inc., a Zimmer Biomet company 
This confidential information about the device is provided for the exclusive use of the investigator(s) and 
is subject to amendments, updates, edits and/or recall at any time.  The information in this document may 
not be disclosed unless federal or state law or regulations require such disclosure.  

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TABLE OF CONTENTS 
Page 
1.
CONTACTS ............................................................................................................................ 5 
2.
SPONSOR SIGNATURE ........................................................................................................ 5 
3.
INVESTIGATOR SIGNATURE ............................................................................................. 6 
4.
DISCLOSURE STATEMENT ................................................................................................ 7 
4.1 
RESTRICTED DISTRIBUTION OF DOCUMENTS .................................................................. 7 
5.
LIST OF ABBREVIATIONS .................................................................................................. 8 
6.
SYNOPSIS .............................................................................................................................. 9 
7.
SCHEDULE OF STUDY EVENTS ...................................................................................... 12 
8.
ETHICAL CONSIDERATIONS ........................................................................................... 12 
8.1 
INSTITUTIONAL REVIEW BOARD ................................................................................... 12 
8.2 
ETHICAL CONDUCT OF THE STUDY ............................................................................... 13 
8.3 
SUBJECT INFORMATION AND CONSENT ......................................................................... 13 
8.4 
SUBJECT CONFIDENTIALITY .......................................................................................... 14 
9.
INTRODUCTION ................................................................................................................. 14 
9.1 
BACKGROUND AND CURRENT TREATMENT ................................................................... 14 
9.2 
BIOWICK SURELOCK IMPLANT ..................................................................................... 14 
9.3 
RATIONALE FOR THIS STUDY ........................................................................................ 14 
10. OBJECTIVES ........................................................................................................................ 15 
10.1 
PRIMARY OBJECTIVE ..................................................................................................... 15 
10.2 
SECONDARY OBJECTIVES .............................................................................................. 15 
11. STUDY DESIGN................................................................................................................... 15 
11.1 
MEASURES TAKEN TO AVOID BIAS ............................................................................... 15 
11.1.1 
RANDOMIZATION ................................................................................................. 15 
11.1.2 
BLINDING ............................................................................................................ 15 
11.1.3 
DESCRIPTION OF THE STUDY DEVICE .................................................................. 15 
12. SELECTION OF STUDY POPULATION ............................................................................ 16 
12.1 
INCLUSION CRITERIA .................................................................................................... 16 
12.2 
EXCLUSION CRITERIA ................................................................................................... 16 
12.3 
SUBJECT WITHDRAWAL ................................................................................................ 17 
13. STUDY PROCEDURES ....................................................................................................... 17 
13.1 
SUBJECT IDENTIFICATION ............................................................................................. 17 
13.2 
SUBJECT ENROLLMENT ................................................................................................. 18 
13.3 
SCREEN FAILURES ......................................................................................................... 18 
13.4 
DESCRIPTION OF STUDY PROCEDURES .......................................................................... 18 

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13.4.1 
MAGNETIC RESONANCE IMAGING ....................................................................... 18 
13.4.2 
VETERANS RAND 12-ITEM HEALTH SURVEY (VR-12) ...................................... 18 
13.4.3 
ASES RATING SCALE .......................................................................................... 19 
13.4.4 
DELIVERY OF BIOWICK SURELOCK IMPLANT ..................................................... 19 
13.5 
PROCEDURES TO BE CONDUCTED AT EACH STUDY SITE VISIT ..................................... 19 
13.5.1 
SCREENING (DAY -28 TO -1) ................................................................................ 19 
13.5.2 
ENROLLMENT/VISIT 1 (DAY 1) ............................................................................ 20 
13.5.3 
THREE MONTHS/VISIT 2 (DAY 90 ± 14 DAYS) .................................................... 20 
13.5.4 
SIX MONTHS/VISIT 3 (DAY 180 ± 30 DAYS) ........................................................ 21 
13.5.5 
12 MONTHS/VISIT 4 (DAY 365 ± 30 DAYS) ......................................................... 21 
13.5.6 
CORONAVIRUS (COVID-19) EXPECTATIONS ...................................................... 21 
14. SAFETY ................................................................................................................................ 22 
14.1 
SAFETY VARIABLES ...................................................................................................... 22 
15. EFFECTIVENESS ................................................................................................................ 22 
15.1 
EFFECTIVENESS VARIABLES .......................................................................................... 22 
15.1.1 
PRIMARY ............................................................................................................. 22 
15.1.2 
SECONDARY ........................................................................................................ 22 
16. STATISTICAL ANALYSIS AND PLANNED ANALYSIS ................................................ 23 
16.1 
INTRODUCTION.............................................................................................................. 23 
16.2 
SAMPLE SIZE AND POWER ............................................................................................. 23 
16.3 
ANALYSIS POPULATIONS ............................................................................................... 23 
16.4 
ANALYSIS SUBGROUPS .................................................................................................. 23 
16.5 
STATISTICAL AND ANALYTICAL PLANS ........................................................................ 23 
16.5.1 
PRIMARY ENDPOINT ANALYSES .......................................................................... 23 
16.5.2 
SECONDARY ENDPOINT ANALYSES ..................................................................... 24 
16.6 
HANDLING MISSING DATA ............................................................................................ 24 
16.7 
INTERIM ANALYSIS ....................................................................................................... 24 
17. ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS .............................................. 24 
17.1 
SAFETY ......................................................................................................................... 24 
17.2 
DEFINITIONS ................................................................................................................. 24 
17.3 
REPORTING OF SERIOUS ADVERSE EVENTS ................................................................... 26 
17.4 
COLLECTING, RECORDING AND REPORTING ADVERSE EVENTS .................................... 26 
18. STUDY SUSPENSION, TERMINATION, AND COMPLETION ...................................... 27 
18.1.1 
TERMINATION BY THE SPONSOR .......................................................................... 27 
18.1.2 
TERMINATION BY THE INVESTIGATOR ................................................................. 28 
19. PROTOCOL AMENDMENTS ............................................................................................. 28 
20. QUALITY CONTROL AND ASSURANCE ........................................................................ 28 
21. DIRECT ACCESS, DATA HANDLING, AND RECORD-KEEPING ................................ 28 

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21.1 
INVESTIGATOR .............................................................................................................. 28 
21.2 
DATA HANDLING .......................................................................................................... 29 
21.2.1 
GENERAL INSTRUCTIONS FOR DATA COLLECTION .............................................. 29 
21.2.2 
DATA SUBMISSION .............................................................................................. 29 
21.2.3 
QUALITY ASSURANCE OF DATA AND MONITORING ............................................. 29 
21.2.4 
STUDY SITE PERSONNEL CHANGES ..................................................................... 30 
21.2.5 
ADVERSE EVENT REPORTING .............................................................................. 30 
21.2.6 
REVIEW OF SOURCE RECORDS ............................................................................. 30 
21.2.7 
MONITORING OF THE STUDY ............................................................................... 30 
22. PUBLICATIONS POLICY ................................................................................................... 31 
REFERENCES ............................................................................................................................. 32 
 

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1.
CONTACTS
Contact the following individuals for all other inquiries and information about this study: 
Program Director 
 
[REDACTED] 
Clinical Study Manager 
[REDACTED] 
2.
SPONSOR SIGNATURE
My signature, in conjunction with the signature of the investigator, confirms the agreement of 
both parties that the clinical study will be conducted in accordance with the protocol and 
applicable laws and other regulations including, but not limited to, the ICH Guideline for Good 
Clinical Practice, the US Code of Federal Regulations, protections for privacy, and generally 
accepted ethical principles for human research such as the Declaration of Helsinki. 
Nothing in this document is intended to limit the authority of a physician to provide emergency 
medical care. 
 Sponsor Representative Signature 
Date of Signature  
(DD MMM YYYY) 
____________________________________________________________________ 
Sponsor Representative Name and Title (print) 

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3.
INVESTIGATOR SIGNATURE
I have read this protocol and agree that it contains all necessary details to carry out the study as 
described.  I will conduct this protocol as outlined herein, including all statements regarding 
confidentiality.  I will make a reasonable effort to complete the study within the time designated.  
I will provide copies of the protocol and access to all information furnished by the Sponsor to 
study personnel under my supervision.  I will discuss this material with them to ensure that they 
are fully informed about the test and the study.  I understand that the study may be terminated or 
enrollment suspended at any time by the Sponsor, with or without cause, or by me if it becomes 
necessary to protect the interests of the study subjects.  Any supplemental information that may 
be added to this document is also confidential and proprietary to Cayenne Medical, Inc., a 
Zimmer Biomet company, and must be kept in confidence in the same manner as the contents of 
this protocol. 
I agree to conduct this study in full accordance with all applicable regulations and Good Clinical 
Practice. 
Investigator’s Signature 
Date of Signature 
(DD MMM YYYY) 
Investigator’s Name (print) 

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4. 
DISCLOSURE STATEMENT 
4.1 
Restricted Distribution of Documents  
This document contains information that is confidential and proprietary to Cayenne Medical, 
Inc., a Zimmer Biomet company  This information is being provided solely for the purpose of 
evaluating and/or conducting the clinical trial for Cayenne Medical, Inc.  You may disclose the 
contents of this document only to study personnel under your supervision, IRBs, or authorized 
representatives of regulatory agencies for this purpose under the condition that they maintain 
confidentiality.   
 
The contents of this document may not be used in any other clinical trial, disclosed to any other 
person or entity, and/or published without the prior written permission of the Sponsor.  The 
foregoing shall not apply to disclosure required by any regulations; however, you will give 
prompt notice to Cayenne Medical, Inc. of any such disclosure. 
 
All other nonpublic information provided by Cayenne Medical, Inc., as well as any information 
that may be added to this document, is also confidential and proprietary to Cayenne Medical, Inc. 
and must be kept in confidence in the same manner as the contents of this document. 
 

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5. 
LIST OF ABBREVIATIONS 
Abbreviation 
Term 
AE 
Adverse Event/Adverse Experience 
CFR 
Code of Federal Regulations 
CRA 
Clinical Research Associate 
CRF 
Case Report Form 
CRO 
Contract Research Organization 
DMP 
Data Management Plan 
EDC 
Electronic Data Capture 
EMG-NCV 
Electromyelopathy and Nerve Conduction Velocity  
FDA 
Food and Drug Administration 
GCP 
Good Clinical Practice 
HIPAA 
Health Insurance Portability and Accountability Act 
ICF 
Informed Consent Form 
ICH 
International Conference on Harmonization 
iCRF 
Internet Case Report Form 
IRB 
Institutional Review Board 
ITT 
Intent to Treat 
IV 
Intravenous 
MCS 
Mental Component Score 
PC 
Personal Computer 
PCS 
Physical Component Score 
PHI 
Protected Health Information 
PI 
Principal Investigator 
SAE 
Serious Adverse Event 
SAS 
Statistical Analysis System 
SDV 
Source Document Verification 
SOC 
Standard of Care 
TEAE 
Treatment Emergent Adverse Event 
UHMWPE 
Ultra High Molecular Weight Polyethylene 
UPS 
United Parcel Service 
USA or U.S. 
United States of America 
USB 
Universal Serial Bus 
VAS 
Visual Analog Scale 
VR-12 
Veterans RAND 12 Item Health Survey 
 
 

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6. 
SYNOPSIS 
Study Title 
Efficacy of the BioWick® SureLock® Implant for the 
Reattachment of Soft Tissue to Bone in Subjects Undergoing 
Rotator Cuff Repairs 
Sponsor 
Cayenne Medical, Inc., a Zimmer Biomet company 
Study Design 
The study is a prospective, non-randomized, open-label, single-
arm study that includes both preoperative assessments and follow-
up assessments at 3 months, 6 months, and 12 months. 
Clinical Phase  
Postmarket  
Number of Sites 
Up to ten sites in the U.S. 
Study Duration per 
Subject 
Subjects will be enrolled in the study for up to 12 months.    
Primary Objective 
The primary objective of this study is to assess survivorship (lack 
of reoperation/device removal) with the use of the BioWick 
SureLock implant.  
Secondary Objective  
The secondary objectives of this study are :  
• 
To document the postmarket effectiveness of the BioWick 
SureLock implant using range of motion measurements, 
ASES scores, VR-12 scores, and VAS scores, with the 
corresponding assessments made at 3 months, 6 months, 
and 12 months. 
• 
To document device safety via device-related adverse 
events reported over the course of the study.  
Primary Endpoint 
The primary endpoint of this study is the BioWick SureLock 
implant survivorship at 12 months post-operative. 
Secondary Endpoints 
The secondary endpoints of this study are: 
• Implant survivorship at visit intervals other than 12 
months 
• VR-12 scores at 3 months, 6 months, and 12 months 
postoperative 
• ASES rating scale at 3 months, 6 months, and 12 
months postoperative 
• VAS pain scores at 3 months, 6 months, and 12 
months postoperative 
• Range of motion (ROM) at 3 months, 6 months, and 
12 months postoperative 
 

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Inclusion Criteria 
Inclusion Criteria 
1. Clinical diagnosis of rotator cuff tear which is greater than or 
equal to 1.5 cm and less than or equal to 4.0 cm full thickness 
of either the supraspinatus or infraspinatus determined by MRI 
which has not been previously repaired; 
2. Goutallier Stage 2 or less; 
3. Patte Stage II (mid humeral head retraction); 
4. Tear(s) confirmed intra-operatively by calibrated probe, tears 
measured in both anterior-posterior and medial-lateral planes; 
5. Subject is skeletally mature at the surgical site; 
6. Subject is able to read and understand the ICF and has 
voluntarily provided written informed consent.  
Exclusion Criteria 
1. Clinical diagnosis of a rotator cuff tear of the subscapularis 
that requires repair (not including debridement); 
2. Conditions which, in the opinion of the Principal Investigator, 
may limit the subject’s ability or willingness to follow post-
operative care or study instructions; 
3. If female, subject is pregnant; 
4. Presence of local or systemic infection;  
5. Suprascapular nerve compression requiring release or 
documented by EMG-NCV; 
6. Substance abuse, including tobacco, alcohol, or illicit drugs 
which, in the investigator’s judgment, could impair healing or 
influence study compliance;  
7. Foreign body sensitivity. If material sensitivity is suspected, 
testing should be completed prior to device implantation; 
8. Insufficient blood supply or previous infection which may 
hinder the healing process; 
9. Subject conditions including: insufficient quantity or quality 
of bone or soft tissue, or immature bone where the device may 
impact or disrupt the growth plate; 
10. Subject is a prisoner or member of another vulnerable 
population; 
11. Cortisone injection within 6 weeks prior to surgical treatment; 
12. Use of immune suppressants or chemotherapeutic medications 
within the last 12 months; 

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13. Use of systemic corticosteroids at any daily dose for more 
than 1 month within the last 12 months. 
Safety Evaluation 
Safety evaluations will be based on the frequency and incidence 
of device related adverse events. 
Planned Sample 
Size 
A maximum of 71 subjects will be enrolled in the study. 
Statistical Analysis 
The following analysis populations will be defined for the study:   
 
Intention to Treat (ITT) Population – The ITT 
population will consist of all subjects who have signed 
informed consent, been enrolled in the study, and have had 
successful placement of the BioWick™ SureLock™ 
implant. 
 
Safety Population – The safety population will consist of 
all subjects who have signed informed consent, been 
enrolled in the study, and have had a procedure during 
which BioWick SureLock implant placement was 
attempted, whether or not placement was successful. 
   
The primary analysis population for all primary and secondary 
endpoints will be the ITT population.  The primary analysis 
population for safety will be the safety population.  
 
Analysis of Primary Endpoint 
Implant survivorship for each subject will be determined by 
whether the subject undergoes a device 
removal/revision/reoperation of the study device.  
 

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7. 
SCHEDULE OF STUDY EVENTS  
     Table 7.1 Study Flowchart of Scheduled Events  
Event 
Screening 
(Day -28 to -1) 
Enrollment/ 
Visit 1 
(Day 1)1 
3 Months/  
Visit 2 
(Day 90 ± 14 
Days) 
6 Months/  
Visit 3 
 (Day 180 ± 30 
Days) 
12 Months/  
Visit 4 Or Early 
Termination 
Visit2 
 (Day 365 ± 30 
Days) 
Informed Consent 
X 
 
 
 
 
Inclusion/Exclusion Criteria 
X 
X 
 
 
 
Medical History 
X 
 
 
 
 
Physical Exam 
X 
 
 
 
 
Concomitant Medications 
X 
X 
X 
X 
X 
BioWick SureLock  
Surgical Implantation 
 
X 
 
 
 
Magnetic Resonance Imaging 
X3 
 
 
 
 
ASES Rating Scale 
X 
 
X 
X 
X 
VR-12 Health Survey 
X 
 
X 
X 
X 
ASES Range of Motion 
X 
 
X 
X 
X 
Adverse Events 
X 
X 
X 
X 
X 
Subject Completion 
 
 
 
 
X 
 
1 Upon meeting all I/E criteria, subjects will be enrolled on Day 1 after final confirmation of intra-operative I/E criteria.  
2 Assessments to be completed if the subject is an early withdrawal and returns to the clinic for a final visit. 
3 A MRI scan obtained within 6 months of screening may be used to confirm I/E criteria. If a MRI scan is not available 
within this time frame, then a screening MRI scan is required.  
8. 
ETHICAL CONSIDERATIONS 
This clinical study is designed to comply with International Conference on Harmonization 
(ICH) Guidance on General Considerations for Clinical Trials (62 FR 66113, 17 Dec 1997),  
Clinical Investigation of Medical Devices for Human Subjects -- Good Clinical Practice 
(ISO14155:2011), and Good Clinical Practice: Consolidated Guidance (62 FR 25692,09 May 
1997). 
 
8.1 
Institutional Review Board 
It is the responsibility of the investigator to obtain the approval of the IRB before the start of 
the study. The IRB must be registered and active with the Office for Human Research 
Protections of the US Department of Health and Human Services. A copy of the approval 
letter along with a roster of IRB members and/or the US Department of Health and Human 
Services Federal Wide Assurance Number will be retained as part of the study records. 
During the course of the study, the investigator will provide timely and accurate reports to the 
IRB on the progress of the study at appropriate intervals (not to exceed 1 year) and at the 
completion of the study. The investigator will notify the IRB of SAEs, protocol deviations or 
other significant safety findings per IRB guidelines. The study protocol, ICF, advertisements 
(if any), and amendments (if any) will be approved by the IRB in conformance with CFR, 
Title 21, Part 56. 
 

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8.2 
Ethical Conduct of the Study 
The study will be conducted in full compliance with applicable FDA regulations and ICH 
guidelines for GCP and in accordance with the ethical principles that have their origins in the 
Declaration of Helsinki. 
 
8.3 
Subject Information and Consent 
A copy of the proposed informed consent documents will be submitted to the Sponsor for 
review and approval before submission to the appropriate IRBs. The study will not begin 
until the documents have been reviewed and approved by the Sponsor and the documents 
have been approved by the IRBs.   
The ICF shall contain all of the elements of informed consent specified in the Code of 
Federal Regulations (21 CFR 50.25) and HIPAA authorization. Copies of the regulations 
relating to informed consent and the protection of human subjects in clinical studies are 
available from the Sponsor. 
 
All potential study subjects will be given copies of the following before participating in any 
screening procedures: 
• The study ICF; 
• Agreement for HIPAA Authorization (if separate from ICF); 
• Any specific documentation that may be required by the site’s IRB.  
 
Subjects will have an opportunity to discuss the contents of these forms with study site staff. 
The study should be thoroughly explained including the purpose of the study, methods, 
anticipated benefits, and potential hazards prior to obtaining written consent. 
Subjects must understand and voluntarily sign these forms in compliance with 21 CFR, Part 
50, before participating in any study-related procedures. Subjects will be made aware that 
they may withdraw from the study at any time.  
 
The subject will be made aware of his/her right to see and copy his/her records related to the 
study for as long as the investigator has possession of this information. If the subject 
withdraws consent and/or HIPAA authorization, the investigator can no longer disclose 
health information, unless it is needed to preserve the scientific integrity of the study.  A copy 
of the signed informed consent document will be given to the subjects for their records. 
 
The subjects will also be informed that their medical records may be reviewed by the study 
Sponsor or designee, quality assurance auditor, or inspector from FDA or similar foreign 
authorities. The subjects will be informed that these persons are bound by the same 
confidentiality obligations as the subject’s physician. 
 
Nothing in these regulations is intended to limit the authority of a physician to provide 
emergency medical care under applicable regulations. Regulations require that Investigators 

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permit the Sponsor, Sponsor representatives, and appropriate regulatory agencies to conduct 
inspections and review records pertaining to clinical investigations. 
The delegation of Investigator responsibilities, including obtaining informed consent, must be 
documented in the study records. 
 
8.4 
Subject Confidentiality 
 
The Principal Investigator and designees, employees, and agents involved with this study will 
comply with relevant state and federal laws relating to the confidentiality, privacy, and 
security of subject’s PHI. They will only create, maintain, use, or disclose any data that is 
generated by this study or other information disclosed to the Principal Investigator or their 
employees or agents during the course of the study to the Sponsor, IRB, FDA, or other 
authorized recipients as appropriate for the execution, analysis, review, and reporting of this 
study. Such information shall not be used for any other purposes and will remain confidential. 
Subject records are only to be identified by initials and subject ID numbers. Subject names 
are not to be transmitted on any document to the Sponsor.  
 
9. 
INTRODUCTION 
9.1 
Background and Current Treatment 
Fixation in soft tissues is traditionally achieved by using a solid anchor which has been 
loaded with non-absorbable sutures, a technique which has proven adequately effective but 
which carries the risk of displacement or relocation of the anchor as well as bone loss and/or 
articular damage. Additionally, existing products require manual “tugging” of the anchor in 
order to achieve deployment, and, in the event that the anchor is not deployed correctly, the 
anchor may subsequently pull out.  
 
9.2 
BioWick SureLock Implant  
 
The BioWick SureLock implant is a device for shoulder and extremity surgery, constructed 
of Ultra High Molecular Weight Polyethylene Suture. BioWick SureLock is uniquely 
designed to minimize these risks by avoiding manual tensioning with an inserter mechanism 
that ensures that the implant is consistently deployed below the cortex.  
 
9.3 
Rationale for This Study 
 
The purpose of this study is to collect postmarket data in subjects who receive surgical 
treatment of a full-thickness rotator cuff tear (of at least 1.5 cm) with the BioWick SureLock 
implant. Both performance and safety data will be collected.         
   

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10. 
OBJECTIVES 
10.1 
Primary Objective 
The primary objective of this study is to assess survivorship (lack of reoperation/device 
removal) with the use of the BioWick SureLock implant. 
 
10.2 
Secondary Objectives 
The secondary objectives of this study are:  
• To document the postmarket effectiveness of the BioWick SureLock implant using 
ASES scores, VR-12 scores, and VAS scores, with the corresponding assessments 
made at 3 months, 6 months, and 12 months postoperative. 
• To document the postmarket effectiveness of the BioWick SureLock implant using 
range of motion (ROM) measurements with the corresponding assessments made at 3 
months and 6 months postoperative.  
• To document device safety via device-related adverse events reported over the course 
of the study.  
      
11. 
STUDY DESIGN  
The study is a prospective, non-randomized, open-label, single-arm, postmarket, multicenter 
study. The schedule of study events list the procedures to be performed in each visit (see 
Table 7.1). 
 
11.1 
Measures Taken to Avoid Bias 
11.1.1 
Randomization 
All subjects enrolled in the study will be treated with the BioWick SureLock implant. As 
there is no comparison arm, there will be no randomization.  
 
11.1.2 
Blinding 
As this study is a single-arm study in which all subjects are treated with the BioWick 
SureLock implant, neither subjects nor investigators will be blinded.      
 
11.1.3 
Description of the Study Device  
The BioWick SureLock implant is a device constructed of ultra-high molecular weight 
polyethylene suture for use in shoulder and extremity surgery. The BioWick SureLock 
implant eliminates manual tensioning through a unique inserter-controlled deployment 
method that prevents partial deployment as well as displacement or partial deployment of the 
anchor by consistent deployment of the anchor below the cortex. The inserter is made of 
surgical grade stainless steel and plastic, and the wick component is made of 85/15 PLGA (L-
lactide-coglucolide).   
 

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12. 
SELECTION OF STUDY POPULATION 
Subjects will be recruited from patients requiring rotator cuff repair surgery or have 
previously had a rotator cuff tear repaired using the BioWick SureLock implant.  
  
12.1 
Inclusion Criteria 
Subjects must meet all of the following inclusion criteria to participate in this study: 
Inclusion Criteria 
1. Clinical diagnosis of rotator cuff tear which is greater than or equal to 1.5 cm and less 
than or equal to 4.0 cm full thickness of either the supraspinatus or infraspinatus 
determined by MRI, which has not been previously repaired; 
2. Goutallier Stage 2 or less; 
3. Patte Stage II (mid humeral head retraction); 
4. Tear(s) confirmed intra-operatively by calibrated probe, tears measured in both 
anterior-posterior and medial-lateral planes; 
5. Subject is skeletally mature at the surgical site; 
6. Subject is able to read and understand the ICF and has voluntarily provided written 
informed consent. 
 
12.2 
Exclusion Criteria 
Any subject who meets any of the exclusion criteria will be excluded from participation in 
this study: 
1. Clinical diagnosis of a rotator cuff tear of the subscapularis that requires repair (not 
including debridement); 
2. Conditions which, in the opinion of the Principal Investigator, may limit the subject’s 
ability or willingness to follow post-operative care or study instructions; 
3. If female, subject is pregnant; 
4. Presence of local or systemic infection;  
5. Suprascapular nerve compression requiring release or documented by EMG-NCV; 
6. Substance abuse, including tobacco, alcohol, or illicit drugs which, in the 
investigator’s judgment,  could impair healing or influence study compliance;  
7. Foreign body sensitivity. If material sensitivity is suspected, testing should be 
completed prior to device implantation; 
8. Insufficient blood supply or previous infection which may hinder the healing process; 
9. Subject conditions including: insufficient quantity or quality of bone or soft tissue, or 
immature bone where the device may impact or disrupt the growth plate; 
10. Subject is a prisoner or member of another vulnerable population; 
11. Cortisone injection within 6 weeks prior to surgical treatment; 
12. Use of immune suppressants or  chemotherapeutic medications within the last 12 
months; 

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13. Use of systemic corticosteroids at any daily dose for more than 1 month within the 
last twelve months. 
        
12.3 
Subject Withdrawal 
Subjects may discontinue from the study at any time.  A subject may be discontinued from 
the study for the following medical or administrative reasons: 
 
• Subject Withdrawal of Consent - Subjects will be free to discontinue from the study at 
any time and for any reason but must notify the study site of their exit from the study.  
• Adverse Event – If during the procedures the subject suffers an AE that, in the judgment 
of the PI, Sponsor or medical monitor, presents an unacceptable consequence or risk to 
the subject, the subject will be discontinued from further participation in the study. 
• Lost to Follow Up – Subjects discontinue from the study without notifying the study site.  
• Serious Protocol Violation – If, during enrollment in the study, the subject fails to 
follow, violates or refuses to participate in any of the procedures described in the protocol 
then the subject will be discontinued from the study at the discretion of the Sponsor.  If, at 
any point during the study, a subject is determined to have been erroneously enrolled into 
the study, the subject will be discontinued from the study due to protocol violation. 
• Other - If the above reasons are not applicable, “Other” will be selected as the option and 
the appropriate reason for subject withdrawal provided. 
 
For subjects who discontinue or are withdrawn from the study for any reason, the PI will 
notify the Sponsor and attempt to recover the following: 
 
• AE occurrences since the last visit to the study site 
• Concomitant medication usage since the last visit to the study site 
If the subject is withdrawn at a study visit, the procedures for an early termination visit will 
be conducted to assess their continued well-being.   
 
 
13. 
STUDY PROCEDURES  
 
13.1 
Subject Identification 
Each subject will be assigned a unique subject number. Subject numbers will not be 
reassigned or reused for any reason.  Only their assigned subject number, initials, and date of 
birth should identify subjects to the Sponsor.  The investigator must maintain a list of 
potential subjects and enrolled subjects using the Subject Screening/Enrollment Log.  
 
Any potential subjects who are pre-screened can be added to the log by recording their 
screening number and initials only. Those who sign the ICF will be assigned a unique study 
ID. 
 

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13.2 
Subject Enrollment 
Subjects who meet all inclusion and exclusion criteria will be considered eligible for 
enrollment.  Subjects will be considered enrolled on Day 1 following final confirmation of 
the intra-operative inclusion/exclusion criteria. Hence, subjects who begin a surgical 
procedure may exit the study as a screen failure.  Once enrolled, a subject may only exit the 
study as a withdrawal (not a screen failure). The reason for withdrawal will be documented 
by the investigator on the Subject Screening/Enrollment Log.  
 
13.3 
Screen Failures 
Subjects who sign an informed consent form and fail to meet the inclusion and/or exclusion 
criteria are defined as screen failures.  For all screen failures, the investigator will record the 
reason for the screen failure on the Subject Screening/Enrollment Log.  A copy of the log will 
be retained in the investigator's study files. 
   
13.4 
Description of Study Procedures 
Subjects enrolled will follow the study procedures outlined in Section 13.   
 
13.4.1 
Magnetic Resonance Imaging  
Magnetic resonance imaging (MRI) of the rotator cuff tear will be obtained during screening 
(baseline). A screening MRI scan will not be required if a MRI scan was obtained within 6 
months of screening based on a review of the subject’s medical history. All pre-operative 
screening or prior qualifying scans and post-operative study scans should be performed on a 
1.5T magnet or better. Additionally, a standardized imaging protocol will be utilized for all 
images collected as part of the study procedures.  
 
All radiographic images will be read and reviewed by Medical Metrics Inc. to confirm 
inclusion criteria. 
 
13.4.2 
Veterans RAND 12-Item Health Survey (VR-12) 
The VR-12 is a 12-item self-administered health survey. The VR-12 consists of eight scales 
which evaluate physical health and mental health.  
 
Physical Health Scales: 
• General Health 
• Physical Functioning 
• Role-Physical  
• Bodily Pain 
 
Mental Health Scales: 
• Role-Emotional 

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• Vitality 
• Mental Health 
• Social Functioning 
 
The responses to the physical health scales will be evaluated to produce the Physical 
Component Score (PCS), and the responses to the mental health scales will be evaluated to 
produce the Mental Component Score (MCS).  Both the PCS and MCS will be determined 
for all subjects at screening, and at 3 months, 6 months, and 12 months postoperative. 
13.4.3 
ASES Rating Scale 
The American Shoulder and Elbow Surgeons (ASES) Functional Questionnaire is an eleven-
item self-report questionnaire consisting of ten questions which evaluate function and one 
question that evaluates pain. The function section of the survey yields a score between 0 and 
30, with a score of zero indicating maximum disability. VAS Pain Score is included and is 
measured on a ten point scale, with a maximum pain score of ten. ASES Ratings will be 
determined for all subjects at screening, and at 3 months, 6 months, and 12 months 
postoperative. 
     
13.4.4 
Delivery of BioWick SureLock Implant 
The approved surgical technique will be followed for delivery of the BioWick SureLock 
Implant. The surgical technique will be provided separately. 
 
13.5 
Procedures To Be Conducted at Each Study Site Visit 
13.5.1 
Screening (Day -28 to -1) 
The screening period of the study will take place up to 28 days prior to enrollment. Subjects 
will visit the study site and receive initial study documents including the ICF. Subjects will 
be given ample time to review and ask any questions about the clinical trial prior to signing 
informed consent. Once informed consent is obtained, the subject will be screened according 
to inclusion and exclusion criteria. 
 
Site personnel will evaluate the subject’s current pain level using the VAS pain scale.  
Disability and function will be assessed through evaluation of ASES scores, VR-12 scores, 
and ROM measurements.  These evaluations will serve as the preoperative baseline scores.  
  
Screening Visit Tasks 
 
• Informed consent 
• Inclusion/exclusion criteria 
• Assess prior medications 
• Medical history 
• Physical exam 

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• MRI exam (may be obtained from medical history within previous 6 months) 
• ASES Physician and Patient Scores  
• VR-12 scores 
• Concomitant Medications 
 
13.5.2 
Enrollment/Visit 1 (Day 1) 
Subjects who meet all pre-operative inclusion/exclusion criteria will return to the study site 
for their surgical procedure and enrollment into the study. Upon arrival at the site and final 
confirmation of the pre-operative inclusion/exclusion criteria, the subject will be prepped for 
the surgical procedure. Final confirmation of the inclusion/exclusion criteria will be made 
intra-operatively, at which point subjects will be enrolled in the study if they continue to be 
study-eligible.  
Standard post-operative care will occur for all subjects according to site procedures. The 
subjects will be assessed for any adverse events that have occurred following the placement 
of the study device and concomitant medications will be recorded. Prior to hospital discharge, 
the site will go over all rehabilitation procedures with the subject per the rehabilitation 
protocol for the study.    
 
Enrollment/Visit 1 Tasks  
 
• Confirm pre-operative inclusion/exclusion criteria 
• Surgical Procedure 
o Confirm intra-operative inclusion/exclusion criteria 
o Use of BioWick SureLock implant 
• Assess any AEs 
 
13.5.3 
3 Months/Visit 2 (Day 90 ± 14 Days) 
Upon arrival at the clinic, site personnel will evaluate the subject’s current pain level using 
the ASES.  Disability and function will be assessed through evaluation of ASES scores and 
VR-12 Scores. The subject will be asked about any adverse health events that have occurred 
since implantation of the device as well as any medications they are taking.  
 
Visit 2 Tasks 
 
• VAS scores 
• ASES scores 
• VR-12 scores 
• ROM measurements 
• Assess AEs 
• Concomitant medications 
 

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13.5.4 
6 Months/Visit 3 (Day 180 ± 30 Days)  
Upon arrival at the clinic, site personnel will evaluate the subject’s current pain level using 
the ASES.  Disability and function will be assessed through evaluation of ASES scores, and 
VR-12 Scores. The subject will be asked about any adverse health events that have occurred 
since the last study visit as well as any medications they are taking.  
 
Visit 3 Tasks 
 
• VAS scores 
• ASES scores 
• VR-12 scores 
• ROM measurements 
• Assess AEs 
• Concomitant medications 
 
13.5.5 
12 Months/Visit 4 (Day 365 ± 30 Days)  
Upon arrival at the clinic, site personnel will evaluate the subject’s current pain level using 
the ASES.  Disability and function will be assessed through evaluation of ASES scores, and 
VR-12 Scores. The subject will be asked about any adverse health events that have occurred 
since implantation of the device as well as any medications they are taking.  
 
Visit 4 Tasks 
 
• VAS scores 
• ASES scores 
• VR-12 scores 
• ROM measurements 
• Assess AEs 
• Concomitant medications 
• Complete Study Completion CRF 
 
After completion of the final procedure required for this visit, the subject’s participation in 
the study is complete, and the site should fill out the Study Completion Case Report Form 
(CRF).  
 
13.5.6 
Coronavirus (COVID-19) Expectations  
If subjects are not allowed at the clinic for visits or if subjects refuse to come into the clinic 
due to COVID-19, then the following tasks should take place: 
 
• Subject questionnaires (VAS, ASES, and VR-12) will be mailed to the subject for 
completion. These questionnaires should not be completed via phone. If the site does 
not receive a response from the subject, the site must attempt to contact the subject 

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and/or re-mail the subject questionnaires at least three (3) times within the visit 
window before submitting a protocol deviation, unless a response is received. 
• The site will attempt to contact the subject to inquire of adverse events that may have 
occurred and/or been resolved since their last visit. The site is required to perform at 
least three (3) contact attempts to obtain this information. These contact attempts must 
be documented in the subject’s study binder. If there is no response by the end of the 
visit window, a note-to-file (NTF) must be added to the subject’s study binder 
indicating new adverse events were not confirmed for the visit.  
• ROM measurements will not be required; however, a protocol deviation must be 
submitted.  
• Label protocol deviations as being related to COVID-19, as applicable  
 
Please note that these expectations are specifically for COVID-19 situations. If a subject 
misses a visit unrelated to COVID-19, this section does not apply and a “Missed Visit” 
protocol deviation will be submitted.  
 
14. 
SAFETY 
14.1 Safety Variables 
Safety will primarily be assessed through frequency and incidence of adverse events.. 
 
15. 
EFFECTIVENESS 
15.1 Effectiveness Variables   
15.1.1 Primary 
The primary endpoint of this study is survivorship (lack of reoperation/device removal) at 12 
months postoperative.    
 
15.1.2 Secondary 
The secondary endpoints of this study are: 
• Implant survivorship at visit intervals other than 12 months 
• VR-12 scores at 3 months, 6 months, and 12 months postoperative 
• ASES rating scale at 3 months, 6 months, and 12 months postoperative 
• VAS pain scores at 3 months, 6 months, and 12 months postoperative 
• Range of motion (ROM) at 3 months, 6 months, and 12 months postoperative 
 
The above endpoints based on continuous data will be reported as both raw and change from 
baseline (CFB) results.  

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16. 
STATISTICAL ANALYSIS AND PLANNED ANALYSIS  
16.1 
Introduction 
This study is a post-marketing, single treatment group, prospective study conducted at up to 
three study centers. The study will be conducted at as many as ten (10) centers in the U.S.  
Subjects will be enrolled in the trial for a period of 12 months.  The objectives of the 
statistical analyses are to evaluate safety and effectiveness of the BioWick SureLock implant 
in the reattachment of soft tissue to bone in rotator cuff repairs.   
A study center is defined as a hospital or medical office under the control and supervision of 
the Principal Investigator.   
 
16.2 
Sample Size and Power 
The study is sized with respect to the primary one-year survivorship endpoint of the study. 
Assuming an observed one-year survivorship of 85%, a total of 59 subjects is required in 
order to estimate the true survivorship within a 95% confidence interval with a half-width 
precision of 10.7%. This assumes a two-sided α=0.05 level of significance and that the data 
come from a binomial distribution. In order to account for a 15% lost-to-follow-up rate, the 
sample size will be upwardly adjusted to 71 total subjects. 
 
16.3 
Analysis Populations 
The following analysis populations will be defined for the study:   
 
ITT Population – The ITT population will consist of all subjects who have signed 
informed consent, been enrolled in the study, and have had a successful placement of 
the BioWick SureLock implant.  
 
Safety Population – The safety population will consist of all subjects who have 
signed informed consent, been rolled in the study and have had a procedure during 
which placement of the BioWick SureLock implant was attempted, whether or not 
placement was successful.  
   
The primary analysis population for all primary and secondary endpoints will be the ITT 
population.  The primary analysis population for safety will be the safety population. 
 
16.4 
Analysis Subgroups 
Analysis subgroups may include age group.  
  
16.5 
Statistical and Analytical Plans 
16.5.1 
Primary Endpoint Analyses 
Implant survivorship for each subject will be determined by whether the subject undergoes a 
revision or reoperation of the study device. Survivorship will be assessed using a Kaplan-

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Meier analysis.  Data will be considered right-censored for all patients that do not have a 
device failure.  For patients lost-to-follow-up, their last available clinical visit will be used as 
the censored date.  For patients that die during the study, their death date will be used as the 
censored date.  The survivorship point estimate and 95% confidence interval about the point 
estimate will be calculated for the one-year primary endpoint.  
 
16.5.2 
Secondary Endpoint Analyses 
Summary statistics (mean, standard deviation, sample size, median, minimum, and 
maximum) will be computed for all quantitative secondary effectiveness endpoints on the raw 
and change from baseline data by time point. Frequency counts and percentages will be 
reported for all categorical secondary effectiveness endpoints.  
 
16.6 
Handling Missing Data 
In the statistical analysis of the primary effectiveness endpoint of the study, only subjects 
with evaluable endpoint will be used in the statistical analysis, i.e., a complete case analysis.   
 
16.7 Interim Analysis 
Interim analysis can be performed at any point during the duration of the study. 
 
17. 
ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS 
Equipment, supplies, and properly skilled personnel must be available to treat any unexpected 
reaction. 
 
17.1 
Safety 
Although major AEs are not anticipated, the investigator must proceed with utmost caution.   
 
The AEs reported will be evaluated as to incidence, relationship to the time the device was 
used, how long the device had been in use, severity, and relationship to the medical device. 
The section on AEs will be tabulated by severity and by Investigator's assessment of the 
event's causative relation to treatment. AE counts by severity level (mild, moderate, and 
severe) will be tabulated. 
 
17.2 
Definitions 
The term "adverse event," as used by the Sponsor, is synonymous with the term "adverse 
experience," which is used by the FDA. 
 
An adverse event for a device is defined as “untoward medical occurrence”.  An adverse 
event is an untoward occurrence that is temporally associated with, but not necessarily related 
to or caused by, the use of the device If the untoward medical occurrence does not involve a 
subject, only occurrences related to the investigational device are included in the definition 
and handled by the Sponsor’s adverse event system. 

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A serious adverse event is defined as any untoward medical occurrence that meets the 
following criteria: 
 
1.   Results in death (i.e., the AE actually causes or leads to death) 
2. 
Is life-threatening (i.e., an AE that, in the opinion of the Investigator, places the 
subject at immediate risk of death) 
3. 
Requires in-patient hospitalization or prolongs an existing hospitalization (i.e., the AE 
requires hospitalization lasting at least 24 hours or prolonged hospitalization beyond 
the expected amount of time; hospitalizations for scheduled medical or surgical 
procedures to conduct scheduled treatments or routine examinations of SAEs do not 
meet these criteria) 
4. 
Results in persistent or significant disability or incapacity (i.e., the AE causes 
substantial disruption in the ability of the subject to carry out normal activities) 
5. 
Is a congenital anomaly or birth defect in the infant/ newborn of a mother that has 
been exposed to the research compound  
6. 
Is considered by the Investigator to be significant medical event based on medical 
criteria (e.g., puts the subject at risk or may require medical or surgical intervention to 
prevent one of the aforementioned results) 
 
 
The seriousness must be evaluated independently from the severity when documenting the 
AEs on the CRF. 
 
Additionally, important medical events that may not result in death, be life threatening, or 
require hospitalization may be considered SAEs when, based on appropriate medical 
judgment, they may jeopardize the subject and may require medical or surgical intervention 
to prevent one of the outcomes listed above.   
 
A life threatening adverse event is any AE that places the subject at immediate risk of death 
from the event as it occurred.  A life-threatening event does not include an event that might 
have caused death had it occurred in a more severe form but that did not create an immediate 
risk of death as it actually occurred. 
 
Hospitalization is to be considered only as an overnight admission.  Hospitalization or 
prolongation of a hospitalization is a criterion for considering an AE to be serious.  In the 
absence of an AE, the participating investigator should not report hospitalization or 
prolongation of hospitalization on a form.  
 
In addition, a hospitalization planned before the start of the study for a preexisting condition 
that has not worsened does not constitute an SAE (e.g. elective hospitalization after the 
procedure was performed and before study completion). 
 
Disability is defined as a substantial disruption in subject’s ability to conduct normal life 
functions. 
 

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17.3 
Reporting of Serious Adverse Events 
This section will address the reporting of the serious adverse event to the Sponsor and/or their 
representatives. 
 
In the event that any SAEs occur during this study, the Investigator will notify the Sponsor or 
the Sponsor’s safety representative via fax or phone immediately after becoming aware of the 
incident. 
 
The Investigator will fax the SAE Report Form, and other documentation regarding the SAE 
to the Sponsor or the Sponsor’s safety representative. The Investigator will promptly provide 
follow-up information requested by the Sponsor or the Sponsor’s safety representative.  
 
17.4 
Collecting, Recording and Reporting Adverse Events 
Adverse events will be recorded from the time a subject has signed the ICF until the subject 
terminates from the study.  The Investigator is responsible for ensuring that all AEs are 
observed and reported during the study on the corresponding AE page of the CRF. 
  
The Investigator will collect AE data at all stages of subject evaluation during the study. AEs 
will be recorded stating the duration (i.e., onset and resolved dates) of the event, the intensity, 
the relationship to the device, the relationship to the surgical procedure, action taken, the 
outcome, the seriousness, regulatory criterion, if any, and the presumed association with the 
study. 
 
Note: The AE must be recorded on the AE page of the CRF.  Each AE should be marked 
appropriately on the AE page as to whether it is serious. An SAE must be reported to the 
Sponsor or the designated safety personnel as soon as possible after the Investigator has 
become aware of its occurrence.  
 
The causal relation between an AE and the study device will be determined by the 
investigator on the basis of his or her clinical judgment and the following definitions: 
 
• Definitely related: Event can be fully explained by administration of the study device. 
• Possibly related: Event may be explained by administration of the study device or by 
the subject’s clinical state or other agents/therapies. 
• Not related: Event can be fully explained by the subject’s clinical state or other 
agents/therapies. 
When assessing the relationship between the study device and an AE, the following should be 
considered: 
 
1. Temporal relationship between the administration of the study device and the AE; 
2. Biological plausibility of relationship; 
3. Subject’s underlying clinical state;  

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4. When applicable, whether the AE abates on discontinuation of the use of the study 
device.  
 
SAEs that are not study related may nevertheless be considered by the participating 
investigator or the medical monitor (or designee) to be related to the conduct of the clinical 
study, i.e., to a subject's participation in the study. For example, a protocol-related SAE may 
be an event that is related to another non-test procedure required by the protocol. 
 
The following definitions should be used when determining the severity of an AE.   
 
• Mild: The AE is noticeable to the subject but does not interfere with activity.   
• Moderate: The AE interferes with routine activity but responds to symptomatic therapy 
or rest.  
• Severe: The AE significantly limits the subject’s ability to perform activities despite 
symptomatic therapy. 
 
18. 
STUDY SUSPENSION, TERMINATION, AND COMPLETION 
The Sponsor may suspend or terminate the study or part of the study at any time for any 
reason. If the investigator suspends or terminates the study, the investigator will promptly 
inform the Sponsor and the IRB and provide them with a detailed written explanation. Upon 
study completion, the investigator will provide the Sponsor, IRB, and regulatory agency with 
final reports and summaries as required by regulations. The investigator must submit a 
written report to the Sponsor and the IRB within three months after the completion or 
termination of the study. Study termination and follow-up will be performed in compliance 
with the Sponsor’s or designee’s standard procedures. 
 
18.1.1 
Termination by the Sponsor 
The Sponsor may terminate the study, or the study site, at any time for any of the following 
reasons: 
1. Failure to enroll subjects 
2. Protocol violations 
3. Inaccurate or incomplete data 
4. Unsafe or unethical practices 
5. Questionable safety of the study device 
6. Suspected lack of appropriateness of the study device 
7. Administrative decision 
 

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18.1.2 
Termination by the Investigator 
If the investigator terminates the study prematurely, the investigator must provide the IRB 
and the Sponsor with a written statement describing why the study was terminated 
prematurely.  Prompt compliance with this requirement is essential so that the Sponsor may 
comply with its regulatory obligations. 
 
19. 
PROTOCOL AMENDMENTS 
Any change in the study plan requires a protocol amendment. An investigator must not make 
any changes to the study without IRB and Sponsor approval except when necessary to 
eliminate apparent immediate hazards to the subjects. A protocol change intended to 
eliminate an apparent immediate hazard to subjects may be implemented immediately, but 
the change must then be documented in an amendment, reported to the IRB and Sponsor 
within 5 working days, and submitted to the appropriate regulatory agency in the required 
time frame.   
 
20. 
QUALITY CONTROL AND ASSURANCE 
The Sponsor performs quality control and quality assurance checks on this clinical study in 
accordance with regulatory agency data integrity requirements and data management SOPs. 
Before enrolling any subjects in the study, the clinical study monitor and the Investigator(s) 
will review the protocol, the IB, the CRF instructions, the procedure for obtaining informed 
consent and the procedure for reporting AEs and SAEs.  
 
A qualified representative of the Sponsor monitors the conduct of the study by visiting the 
site, by contacting the site by telephone, and sending emails.  During the visits, information 
recorded on the CRFs is verified against source documents.  The Sponsor’s medical monitor 
or designee reviews the data for safety information.  The Sponsor’s clinical data associates or 
designees review the data for legibility, completeness, and logical consistency.   
 
Additionally, the Sponsor’s clinical data associates or designees use automated validation 
programs to help identify missing data, selected protocol violations, out-of-range data, and 
other data inconsistencies.  Access to the database shall be limited to appropriate personnel, 
per 21 CFR Part 11 compliance. 
 
21. 
DIRECT ACCESS, DATA HANDLING, AND RECORD-KEEPING 
21.1 Investigator 
The investigator will permit study-related monitoring, audits, IRB review, and regulatory 
inspections by providing direct access to original source data and documents. All subject 
information will be recorded on source documents. The CRFs must be fully completed and 
include all required data for all subjects enrolled. All CRF data must be submitted to the 
Sponsor throughout and at the end of the study. 
 

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21.2 
Data Handling 
21.2.1 General Instructions for Data Collection  
 
Data will be collected on CRFs.  Data will be collected either via paper or electronic CRFs. 
The Investigator will be responsible for the accuracy and completeness of the CRFs. When 
submitted electronically, CRF completion will be tracked by the user name and password of 
the Investigator or designee.   This electronic data collection utility, an image archive, will be 
tested, validated, and documented prior to data collection and submission. All electronic 
systems are validated according to 21 CFR Part 11 and Good Clinical Practice standards. 
Appropriate audit trials exist on both the front and back end of the data management systems. 
Back-up files are maintained by the Sponsor in accordance with 21 CFR Part 11. Access to 
investigative folders will be controlled through user name and passwords, and each site will 
have access to their electronic folder throughout the course of the study. 
 
21.2.2 Data Submission  
 
Completed Case Report Forms must be sent directly to the Sponsor for data load, validation 
and analysis. Every effort should be made to ensure data submission to the Sponsor within 30 
days of visit completion. 
 
21.2.3 Quality Assurance of Data and Monitoring 
 
Cayenne Medical Inc. or its designee will monitor and ensure this investigation is conducted 
in accordance with the signed Clinical Trial Agreement, the Investigational Plan, conditions 
imposed by the Institutional Review Boards and the requirements of Title 21, Code of 
Federal Regulations, Part 50, 54, 56, and 812. 
 
The Sponsor will conduct a site initiation visit to ensure the investigators and staff have 
adequate time and resources to implement and follow the investigational plan, and ensure the 
investigators have access to the target patient population under study. Prior to initiation of the 
study, the investigator must have a fully executed Clinical Trial Agreement and IRB/EC 
approval of this investigational plan and informed consent. 
 
During the investigation, the Sponsor will conduct periodic monitoring visits and maintain 
contact with the investigators and staff to monitor investigational plan compliance and 
evidence of subject related adverse events. The clinical study manager will report any non-
compliance with the signed Clinical Trial Agreement, investigational plan, applicable 
regulations, or any condition of approval imposed by the reviewing IRB/EC to the Sponsor.   
 
CRFs will be routinely reviewed by the Sponsor for completeness and accuracy and any 
evidence of increased subject risk. When any discrepancies are identified, they will be 
addressed with the investigator or qualified designee. 
 

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21.2.4 
Study Site Personnel Changes 
If an investigator retires, relocates, or otherwise withdraws from conducting the study, the 
investigator must notify the Sponsor to agree upon an acceptable storage solution. The IRB 
will be notified with the appropriate documentation. 
 
21.2.5 
Adverse Event Reporting 
The investigator agrees to report all AEs to the Sponsor as described in the Adverse Events 
section.  Furthermore, the investigator is responsible for ensuring that any co-investigator or 
sub-investigator promptly brings AEs to the attention of the investigator.  If applicable, the 
investigator also is responsible for informing the participating IRB of any SAEs. 
 
21.2.6 
Review of Source Records 
Source documents will be maintained on site and will consist of but not be limited to: 
handwritten progress notes, completed Sponsor provided template source documents, subject 
diary, dictated results, study logs, and study-specific site-generated documents. 
The investigator agrees that qualified representatives of the Sponsor and regulatory agencies 
will have the right, both during and after this study, to conduct inspections and to audit and 
review medical records pertinent to the clinical study as permitted by the regulations.  
Subjects will not be identified by name, and confidentiality of information in medical records 
will be preserved. The confidentiality of the subject will be maintained unless disclosure is 
required by regulations. Accordingly, the following statements (or similar statement) will be 
included in the informed consent document. 
 
Representatives of regulatory agencies, IRBs, the Sponsor, and your personal physician may 
review your medical records and all information related to this study as permitted by law.  
Identifying information will not appear on any record received by the Sponsor.  Subject 
identity will remain confidential unless disclosure is required by law.    
 
 
21.2.7 
Monitoring of the Study 
This study is monitored by a representative of the Sponsor.  Site visits may be made before 
the study begins, at regular intervals during the study, and at the study closeout.  
Communication by telephone and mail and e-mail may be used as needed to supplement site 
visits.  The investigator and study site will permit monitoring, audits, IRB review, and 
regulatory inspection by providing authorized personnel from the Sponsor, its representatives, 
the IRB, the FDA and other appropriate regulatory agency direct access to all study data. Any 
party with direct access should take reasonable precautions to maintain the confidentiality of 
the study subjects and Cayenne Medical Inc.’s proprietary information. The purpose of the 
site visits is to verify the following:  
 
1. Adherence to the protocol.  (The investigator should document and explain any deviation 
from the approved protocol.) 

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2. The completeness and accuracy of the CRFs. Adequate time and space for these visits 
should be allocated by the investigator.  
3. Compliance with regulations.  The verification will require comparison of the source 
documents to the CRFs. 
4. All subject records have complete, accurate and plausible ICFs and all study-specific 
logs. 
22. 
PUBLICATIONS POLICY 
The Sponsor will be responsible for determining when the study results should be published.  
The Sponsor will work jointly with the investigators to publish information.  The investigator 
shall not submit a publication to journals or professional societies without agreement and 
prior written approval of the Sponsor. 
 
 
 
 

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REFERENCES 
 
 
1. Patel, Manish. M.D.  Biomechanical Pullout Strength and Cyclic Testing of the 
SureLock™ All Suture Anchors.      
2. Barber et al. Cyclic Load Testing of Biodegradable Suture Anchors Containing 2 High-
Strength Sutures. Arthroscopy 2007 4:355-360