Post-market Clinical Follow-up (PMCF) Study on PEEK Suture Anchors for Shoulder Indications
Conditions: Soft Tissue to Bone Fixation
Sponsor: Smith & Nephew, Inc.

 
Study Protocol
Device 
PMCF Study on PEEK Suture Anchors for Shoulder 
Indications 
Number:
2018.16.SMD.PEEK.RET.SHD 
Version: 2.0,  01April19
Page:  1 of 77 
 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
SOP-059 Clinical Protocols 
 
 
PMCF Study on PEEK Suture Anchors for Shoulder Indications 
 
 
Protocol Number: 
2018.16.SMD.PEEK.RET.SHD 
Protocol Version:  
Version 2.0 
Date: 
 01 April 19 
Study Product Names: 
PEEK Shoulder Suture Anchors 
Healicoil PK Preloaded Suture Anchors 
Bioraptor 2.3 PK Suture Anchors/ 
Bioraptor Curved 2.3 PK Suture Anchors 
Bioraptor Knotless Suture Anchors 
Multifix S Ultra Knotless Fixation System 
Footprint Ultra PK Suture Anchors 
Twinfix Ultra PK Suture Anchors/ 
Twinfix Ultra Preloaded and with needles 
SpeedScrew 
SpeedLock  
 
Sponsor: 
Smith & Nephew Orthopaedics 
7135 Goodlett Farms Parkway 
Cordova, TN 38016 
 
 
 

Study Protocol
Device
PMCF Study on PEEK Suture Anchors for Shoulder 
Indications
Number:
2018.16.SMD.PEEK.RET.SHD
Version: 2.0, 01April19
Page: 2 of 77
CONFIDENTIAL AND PROPRIETARY
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew.
TMP-110 
Clinical Protocol - Devices 
SOP-059 Clinical Protocols
SIGNATURES
1.1 PROTOCOL SIGNATURE PAGE
This page will be returned to Smith & Nephew Inc. and a copy retained at the investigational site.
I have read t
PMCF Study on PEEK Suture Anchors for Shoulder
Indications
2.0, dated 01 April 19, and agree to abide by all provisions set forth herein.
I agree to comply with the Investigator
Obligations stipulated in Section 26.1 of the protocol, 
I agree to ensure that the confidential information contained in this document will not be used for 
any purpose other than the conduct of the described clinical investigation without the prior written 
consent of Smith & Nephew, Inc.
Role
Name
Signature*
Date Signed*
(DD-MMM-YYYY)
Principal Investigator

Study Protocol
Device
PMCF Study on PEEK Suture Anchors for Shoulder 
Indications
Number:
2018.16.SMD.PEEK.RET.SHD
Version: 2.0, 01April19
Page: 3 of 77
CONFIDENTIAL AND PROPRIETARY
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew.
TMP-110 
Clinical Protocol - Devices 
SOP-059 Clinical Protocols
REVISION HISTORY, OWNERSHIP, AND APPROVALS:
2.1 REVISION HISTORY
[Intentionally Left Blank]

Study Protocol
Device
 
PMCF Study on PEEK Suture Anchors for Shoulder 
Indications 
Number: 
2018.16.SMD.PEEK.RET.SHD 
Version: 2.0,  01April19 
Page:  4 of 77 
 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is intended for use only by Smith & Nephew and its 
manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
SOP-059 Clinical Protocols 
 
Version  
 
Page 
Item 
Original 
New 
Reason 
1.0 
N/A 
N/A 
Initial Protocol 
Revision 2.0 
 
N/A 
2.0 
2 
Protocol 
Signature Page 
1.0 
12Sep18 
2.0 
01April19 
Administrative 
2.0 
3 
Revision 
History 
Initial  
Protocol Amendment 2 
Administrative 
2.0 
23 
Signatures 
Sponsor Signatures 
Removed duplicate sponsor signature lines 
Administrative 
2.0 
24, 43 
Part Numbers  
N/A 
Added: Part numbers as of September 2018 
Administrative 
2.0 
24 
Synopsis 
N/A 
Grouped Twinfix Ultra PK Suture Anchors with Twinfix 
Ultra Preloaded and with Needles 
Administrative/Clarification 
2.0 
26 
Min/Max 
Minimum, n=160 
Maximum, n=320 
 
Minimum number of subjects, n=160 
Maximum number of subjects, n=960 
 
Administrative/Clarification 
2.0 
26 
Enrollment 
Distribution 
N/A 
Enrollment distribution: 
Up to three sites will enroll a maximum of 40 subjects 
per anchor configuration; therefore, no more than 120 
subjects will be enrolled for any anchor type.   
 
Rationale for enrollment 
distribution among sites 
and between anchors. 
2.0 
26 
Sample Size 
PEEK 
Anchor 
Minimum  Maximum   
  
Administrative/Clarification 

Study Protocol
Device
 
PMCF Study on PEEK Suture Anchors for Shoulder 
Indications 
Number: 
2018.16.SMD.PEEK.RET.SHD 
Version: 2.0,  01April19 
Page:  5 of 77 
 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is intended for use only by Smith & Nephew and its 
manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
SOP-059 Clinical Protocols 
 
Version  
 
Page 
Item 
Original 
New 
Reason 
Healicoil PK 
Preloaded 
Suture 
Anchors 
 
20  
40  
Bioraptor 
2.3 PK / 
Bioraptor 
Curved 2.3 
PK 
20  
40  
Bioraptor 
Knotless 
Suture 
Anchor 
 
20  
40  
Multifix S 
Ultra 
Knotless 
Fixation 
System 
 
20  
40  
Footprint 
Ultra PK 
20  
40  
PEEK 
Anchor 
Minimum 
Number 
of 
Subjects 
Maximum  
Number 
of 
Subjects 
Maximum 
Number 
of 
Subjects 
for the 
Study 
Healicoil PK 
Preloaded 
Suture 
Anchors 
 
20 
subjects 
per site 
40 
subjects 
per site 
120 
subjects 
Bioraptor 
2.3 PK / 
Bioraptor 
Curved 2.3 
PK 
20 
subjects 
per site 
40 
subjects 
per site 
120 
subjects 
Bioraptor 
Knotless 
Suture 
Anchor 
 
20 
subjects 
per site 
40 
subjects 
per site 
120 
subjects 

Study Protocol
Device
 
PMCF Study on PEEK Suture Anchors for Shoulder 
Indications 
Number: 
2018.16.SMD.PEEK.RET.SHD 
Version: 2.0,  01April19 
Page:  6 of 77 
 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is intended for use only by Smith & Nephew and its 
manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
SOP-059 Clinical Protocols 
 
Version  
 
Page 
Item 
Original 
New 
Reason 
Suture 
Anchor 
 
Twinfix Ultra 
PK Suture 
Anchors/ 
Twinfix Ultra 
Preloaded 
and with 
needles 
 
 
20  
40  
SpeedScrew 
 
20  
40  
SpeedLock  
 
20  
40  
 
Multifix S 
Ultra 
Knotless 
Fixation 
System 
 
20 
subjects 
per site 
40 
subjects 
per site 
120 
subjects 
Footprint 
Ultra PK 
Suture 
Anchor 
 
20 
subjects 
per site 
40 
subjects 
per site 
120 
subjects 
Twinfix Ultra 
PK Suture 
Anchors/ 
Twinfix Ultra 
Preloaded 
and with 
needles 
 
 
20 
subjects 
per site 
40 
subjects 
per site 
120 
subjects 
SpeedScrew 
 
20 
subjects 
per site 
40 
subjects 
per site 
120 
subjects 

Study Protocol
Device
 
PMCF Study on PEEK Suture Anchors for Shoulder 
Indications 
Number: 
2018.16.SMD.PEEK.RET.SHD 
Version: 2.0,  01April19 
Page:  7 of 77 
 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is intended for use only by Smith & Nephew and its 
manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
SOP-059 Clinical Protocols 
 
Version  
 
Page 
Item 
Original 
New 
Reason 
SpeedLock  
 
20 
subjects 
per site 
40 
subjects 
per site 
120 
subjects 
Total 
160 
subjects 
320 
subjects 
960 
subjects 
 
 
 
2.0 
27 
Number of 
Study Sites 
Up to 9 sites 
Up to 16 sites 
Increase the number of 
investigative sites 
2.0 
27 
Inclusion 
Criteria 
1. 
Subjects who have undergone 
shoulder joint repair using the 
study devices.  
2. Subjects aged 18 years and 
older at the time of surgery. 
 
1. 
Subjects who have undergone shoulder joint 
repair using the study devices.  
2. Subjects aged 18 years and older at the time of 
surgery. 
3.  Subjects must have had a visit to their provider 
between 3 and 15 months post-operative. 
Clarification 
2.0 
28 
Exclusion 
Criteria 
1. 
Subjects who are < 12 months 
post-operative. 
2. Subject is entered in another 
investigational drug, biologic, or 
device study or has been 
treated with an investigational 
1. 
Subjects who are < 12 months post-operative. 
2. Subject is entered in another investigational 
drug, biologic, or device study or has been 
treated with an investigational product within 30 
days prior to surgery. 
Clarification 

Study Protocol
Device
 
PMCF Study on PEEK Suture Anchors for Shoulder 
Indications 
Number: 
2018.16.SMD.PEEK.RET.SHD 
Version: 2.0,  01April19 
Page:  8 of 77 
 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is intended for use only by Smith & Nephew and its 
manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
SOP-059 Clinical Protocols 
 
Version  
 
Page 
Item 
Original 
New 
Reason 
product within 30 days prior to 
surgery. 
 
3. Off-label use of the PEEK suture anchor during 
surgery. 
2.0 
28, 49 
Primary 
Endpoint 
Clinical success rate (%) at 6 months 
post-operative. 
Clinical success rate (%) at 6 months post-operative 
based on standard of care. 
Clarification 
2.0 
28, 49 
Secondary 
Endpoint 
Clinical success rate (%) at 12 months 
post-operative. 
Clinical success rate (%) at 12 months post-operative 
based on standard of care. 
Clarification 
2.0 
29 
SOE/ICF 
NA if waiver of consent approved by IRB 
NA if waiver of consent granted by IRB 
Clarification 
2.0 
29 
SOE/Footnote 
NA 
2  End of Study CRF can be completed at 6 months if the 
subject did not have a 12 month visit. 
 
Clarification 
2.0 
33 
List of 
Abbreviations 
BMI 
ITT 
mITT 
PHI 
PROs 
Removed.  Not applicable. 
Administrative 
2.0 
Throughout 
Minor 
formatting 
corrections 
__ 
___ 
Administrative 

Study Protocol
Device
 
PMCF Study on PEEK Suture Anchors for Shoulder 
Indications 
Number: 
2018.16.SMD.PEEK.RET.SHD 
Version: 2.0,  01April19 
Page:  9 of 77 
 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is intended for use only by Smith & Nephew and its 
manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
SOP-059 Clinical Protocols 
 
Version  
 
Page 
Item 
Original 
New 
Reason 
2.0 
36 
IFUs 
PEEK Suture 
Anchor 
IFU 
Healicoil PK 
Preloaded Suture 
Anchors 
10600803 2/17, 
Rev D 
Bioraptor 2.3 PK 
Suture Anchors 
10600304 1/17, 
Rev D 
Bioraptor Curved 
2.3 PK Suture 
Anchors 
Bioraptor Knotless 
Suture Anchors 
10600479 2/17, 
Rev E 
Multifix S Ultra 
Knotless Fixation 
System 
P/N 65101 4/17, 
Rev B 
Footprint Ultra PK 
Suture Anchors 
10600584 2/17, 
Rev E 
Twinfix Ultra PK 
Suture Anchors 
Twinfix Ultra 
Preloaded and 
with needles 
10600332 1/17, 
Rev E 
SpeedScrew 
P/N 62528 3/17, 
Rev C 
PEEK Suture Anchor 
IFU 
Healicoil PK Preloaded 
Suture Anchors 
10600803 2/17, Rev D 
Bioraptor 2.3 PK Suture 
Anchors 
10600304 1/17, Rev 
D/10600778 Rev D 
Bioraptor Curved 2.3 PK 
Suture Anchors 
Bioraptor Knotless Suture 
Anchors 
10600479 2/17, Rev E 
Multifix S Ultra Knotless 
Fixation System 
P/N 65101 4/17, Rev B 
Footprint Ultra PK Suture 
Anchors 
10600584 2/17, Rev E 
Twinfix Ultra PK Suture 
Anchors 
Twinfix Ultra Preloaded 
and with needles 
10600332 1/17, Rev E/ 
10600677 Rev C 
SpeedScrew 
P/N 62528 3/17, Rev C 
SpeedLock  
P/N 62513 8/18, Rev D 
 
Administrative 

Study Protocol
Device
 
PMCF Study on PEEK Suture Anchors for Shoulder 
Indications 
Number: 
2018.16.SMD.PEEK.RET.SHD 
Version: 2.0,  01April19 
Page:  10 of 77 
 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is intended for use only by Smith & Nephew and its 
manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
SOP-059 Clinical Protocols 
 
Version  
 
Page 
Item 
Original 
New 
Reason 
SpeedLock  
P/N 62513 8/18, 
Rev D 
 
2.0 
36 
IFU 
N/A 
Instructions for Use have been provided as a reference 
but may not have been the version used at the time of 
surgery. 
 
Clarification 
2.0 
39 
Bioraptor 
Knotless 
Suture Anchor 
N/A 
Image of the device provided. 
Administrative 
2.0 
46 
Subject 
Population 
Enrollment will be in sequential order 
based on the date of their surgical 
procedure with the investigational 
device, i.e. earliest to latest. 
Enrollment will be in sequential order based on the date 
of their surgical procedure with the investigational 
device, i.e. time of surgery to present day. 
Clarification 
2.0 
46 
Inclusion 
Criteria 
1. 
Subjects who have undergone 
shoulder joint repair using the 
study devices.  
2. Subjects aged 18 years and 
older at the time of surgery. 
 
1. 
Subjects who have undergone shoulder joint 
repair using the study devices.  
2. Subjects aged 18 years and older at the time of 
surgery. 
3.  Subjects must have had a visit to their provider 
between 3 and 15 months post-operative. 
Clarification 
2.0 
46 
Exclusion 
Criteria 
1. 
Subjects who are < 12 months 
post-operative. 
2. Subject is entered in another 
investigational drug, biologic, or 
1. 
Subjects who are < 12 months post-operative. 
2. Subject is entered in another investigational 
drug, biologic, or device study or has been 
Clarification 

Study Protocol
Device
 
PMCF Study on PEEK Suture Anchors for Shoulder 
Indications 
Number: 
2018.16.SMD.PEEK.RET.SHD 
Version: 2.0,  01April19 
Page:  11 of 77 
 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is intended for use only by Smith & Nephew and its 
manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
SOP-059 Clinical Protocols 
 
Version  
 
Page 
Item 
Original 
New 
Reason 
device study or has been 
treated with an investigational 
product within 30 days prior to 
surgery. 
 
treated with an investigational product within 30 
days prior to surgery. 
3.  Off-label use of the PEEK suture anchor during 
surgery. 
2.0 
47 
LTFU 
A subject will be considered lost to 
follow-up if he/she did not return for 
follow-
of care. 
N/A 
Removed as it is not 
applicable to this study. 
2.0 
48 
Study Design 
This is a retrospective, open-label, 
multicenter study to collect clinical data 
that will evaluate post-market safety and 
performance of the PEEK suture anchors 
in the shoulder. A minimum of 160 
subjects and maximum of 320 subjects 
in the United States who underwent 
surgery in the shoulder using the Smith 
& Nephew PEEK anchor sutures are 
planned to be enrolled into the study 
This is a retrospective, open-label, multicenter study to 
collect clinical data that will evaluate post-market safety 
and performance of the PEEK suture anchors in the 
shoulder. A minimum of 160 subjects and maximum of 
960 subjects in the United States who underwent 
surgery in the shoulder using the Smith & Nephew PEEK 
anchor sutures are planned to be enrolled into the study 
after the fulfillment of all inclusion and exclusion criteria. 
Up to three sites will enroll a minimum of 20 subjects and 
a maximum of 40 subjects per anchor configuration; 
Clarification 

Study Protocol
Device
 
PMCF Study on PEEK Suture Anchors for Shoulder 
Indications 
Number: 
2018.16.SMD.PEEK.RET.SHD 
Version: 2.0,  01April19 
Page:  12 of 77 
 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is intended for use only by Smith & Nephew and its 
manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
SOP-059 Clinical Protocols 
 
Version  
 
Page 
Item 
Original 
New 
Reason 
after the fulfillment of all inclusion and 
exclusion criteria. It is also planned that 
each investigational site will enroll a 
minimum of 20 subjects. 
 
therefore, no more than 120 subjects will be enrolled for 
any anchor type.   
Table 4. Added 
 
2.0 
49 
Secondary 
Endpoint 
The secondary endpoint will be clinical 
success rate (%) at 12 months post-
operative based on standard of care.  
Clinical success has previously been 
defined.   
The secondary endpoint will be clinical success rate (%) 
at 12 months post-operative based on standard of care.  
Clinical success has previously been defined.  It is 
clinical data may not be available for all subjects.  
 
Clarification 
2.0 
51 
Concomitant 
Medications 
and Therapies 
Any concomitant medications associated 
with an AE, SAE or SADE will be 
recorded.   
 
Any concomitant medications associated with an AE, SAE 
or SADE will be recorded.  Concomitant medications will 
be recorded from the time of surgery through 12 months.  
Clarificaiton 

Study Protocol
Device
 
PMCF Study on PEEK Suture Anchors for Shoulder 
Indications 
Number: 
2018.16.SMD.PEEK.RET.SHD 
Version: 2.0,  01April19 
Page:  13 of 77 
 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is intended for use only by Smith & Nephew and its 
manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
SOP-059 Clinical Protocols 
 
Version  
 
Page 
Item 
Original 
New 
Reason 
concomitant medications will be collect through 6 
months. 
 
2.0 
52 
General 
group will conduct the statistical analysis 
for this study. Unless otherwise stated, 
all significance tests will be two-sided, 
performed at the 5% significance level. 
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. 
Clarification 
2.0 
52 
General 
Resulting p-values will be quoted and 
95% two-sided confidence intervals will 
be generated where appropriate. 
Resulting p-values will be provided and 95% two-sided 
confidence intervals will be generated where 
appropriate. 
Clarification 
2.0 
53 
Safety Analysis 
A listing of concomitant medications will 
be provided by subject for AEs, 
 
A listing of concomitant medications will be provided by 
subject. 
 
Clarification 

Study Protocol
Device
 
PMCF Study on PEEK Suture Anchors for Shoulder 
Indications 
Number: 
2018.16.SMD.PEEK.RET.SHD 
Version: 2.0,  01April19 
Page:  14 of 77 
 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is intended for use only by Smith & Nephew and its 
manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
SOP-059 Clinical Protocols 
 
Version  
 
Page 
Item 
Original 
New 
Reason 
2.0 
54 
Other Endpoint 
Analysis 
The derivation of surgeon reported 
outcomes used in summarizing this data 
for the study 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 derivation of surgeon reported outcomes used in 
summarizing this data for the study will be described in 
the SAP and will be summarized as appropriate using 
descriptive summary characteristics for continuous or 
categorical endpoints at 6 months and 12 months. 
 
Clarification  
2.0 
55 
 
Sample Size 
Justification 
With an assumption of a 91% clinical 
success rate to be obtained in each of 
the PEEK anchor sutures and a 
With an assumption of a 91% clinical success rate to be 
obtained in each of the PEEK anchor sutures and a 
corresponding 95% CI between 80% and 100%, enrolling 
Clarification 

Study Protocol
Device
 
PMCF Study on PEEK Suture Anchors for Shoulder 
Indications 
Number: 
2018.16.SMD.PEEK.RET.SHD 
Version: 2.0,  01April19 
Page:  15 of 77 
 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is intended for use only by Smith & Nephew and its 
manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
SOP-059 Clinical Protocols 
 
Version  
 
Page 
Item 
Original 
New 
Reason 
corresponding 95% CI between 80% and 
100%, enrolling between 20 and 40 
precision analysis will provide between 
15.2% to >95% probability.  Thus, an 
overall minimum of 160 and maximum of 
320 subjects who had previously 
undergone surgery of the shoulder using 
PEEK anchor sutures will be enrolled into 
the study. Additionally, a minimum of 20 
subjects will be enrolled at any 
investigational site.   
 
between 20 and 120 subjects for each PEEK anchor 
>95% probability.  Thus, an overall minimum of 160 and 
maximum of 960 subjects who had previously 
undergone surgery of the shoulder using PEEK anchor 
sutures will be enrolled into the study. Additionally, a 
minimum of 20 subjects will be enrolled at any 
investigational site.   
 
2.0 
55 
AE Definitions 
All adverse events will be captured. 
All adverse events will be captured from the time of 
surgery through the 12 month follow-up visit. 
Clarification 

Study Protocol
Device
 
PMCF Study on PEEK Suture Anchors for Shoulder 
Indications 
Number: 
2018.16.SMD.PEEK.RET.SHD 
Version: 2.0,  01April19 
Page:  16 of 77 
 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is intended for use only by Smith & Nephew and its 
manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
SOP-059 Clinical Protocols 
 
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Reason 
2.0 
59 
Reporting 
Procedures 
AE of any kind and DevD will be recorded 
in the applicable CRF and source notes. 
The Investigator will evaluate all AE for 
relationship to the device and procedure, 
if applicable, seriousness, and severity. 
ADE, SAE, and DevD will be entered into 
the CRF and reported to the Sponsor 
within 24 hours of the investigator being 
informed about the event (Figure 1).   For 
ADE and DevD, details of the 
product/procedure related to the event 
will be included and where applicable, 
pictures taken of the device.  The 
deficient product should be retained for 
return to S&N unless it is contaminated 
(e.g. used dressings must not be 
retained). Updates to submitted 
AE of any kind and DevD will be recorded in the 
applicable CRF and source notes. The Investigator will 
evaluate all AE for relationship to the device and 
procedure, if applicable, seriousness, and severity. ADE, 
SAE, and DevD will be entered into the CRF and reported 
to the Sponsor within 24 hours of the investigator being 
informed about the event (Figure 1).   Applicable to the 
retrospective study design, 24 hour reporting begins at 
the time the Investigator was informed of the event under 
the auspice of the clinical study.  For ADE and DevD, 
details of the product/procedure related to the event will 
be included and where applicable and available, pictures 
taken of the device.  If available, the deficient product 
should be retained for return to S&N unless it is 
contaminated (e.g. used dressings must not be retained).  
 
Clarification implemented 
as it is applicable for a 
retrospective study. 

Study Protocol
Device
 
PMCF Study on PEEK Suture Anchors for Shoulder 
Indications 
Number: 
2018.16.SMD.PEEK.RET.SHD 
Version: 2.0,  01April19 
Page:  17 of 77 
 
 
CONFIDENTIAL AND PROPRIETARY 
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manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
SOP-059 Clinical Protocols 
 
Version  
 
Page 
Item 
Original 
New 
Reason 
information will be recorded in the CRF 
within 24 hours of the information being 
available to the investigator. 
 
2.0 
N/A  
Follow-up of 
Subjects with 
Adverse Events  
For subjects who are experiencing 
ongoing unresolved AE at the time of 
their study completion or early 
discontinuation from the study, it is 
recommended that the Investigator 
schedule an appropriate follow-up visit in 
order to determine the outcome of the 
event.  
 
Any additional data must be documented 
and available to the Sponsor who will 
determine whether the data need to be 
Removed 
Clarification implemented 
as it is applicable for a 
retrospective study 

Study Protocol
Device
 
PMCF Study on PEEK Suture Anchors for Shoulder 
Indications 
Number: 
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Version: 2.0,  01April19 
Page:  18 of 77 
 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is intended for use only by Smith & Nephew and its 
manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
SOP-059 Clinical Protocols 
 
Version  
 
Page 
Item 
Original 
New 
Reason 
documented within the CRF/Clinical 
Study Report. 
 
2.0 
N/A  
Ongoing 
Adverse Events 
at Study 
Discontinuation 
Adverse events which are related to a 
study procedure or S&N IP and are 
The event should be followed until it is 
either resolved or until the event has 
become chronic and is not expected to 
review of the event. 
 
Adverse events which are not related to 
a study procedure or S&N IP and are 
should be followed for 30 days after 
Removed 
Clarification implemented 
as it is applicable for a 
retrospective study 

Study Protocol
Device
 
PMCF Study on PEEK Suture Anchors for Shoulder 
Indications 
Number: 
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Version: 2.0,  01April19 
Page:  19 of 77 
 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is intended for use only by Smith & Nephew and its 
manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
SOP-059 Clinical Protocols 
 
Version  
 
Page 
Item 
Original 
New 
Reason 
discontinuation or if the AE is resolved, 
whichever is sooner. 
 
At the time of data analysis (e.g. interim 
or final), an evaluation of ongoing events 
should take place and be listed as 
ongoing in the safety table. 
 
62 
Investigator 
Obligations 
(Financial 
Disclosure) 
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. 
 
Removed  
Clarification- Financial 
disclosures is not 
applicable. 

Study Protocol
Device
 
PMCF Study on PEEK Suture Anchors for Shoulder 
Indications 
Number: 
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Page:  20 of 77 
 
 
CONFIDENTIAL AND PROPRIETARY 
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manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
SOP-059 Clinical Protocols 
 
Version  
 
Page 
Item 
Original 
New 
Reason 
 
62 
Sponsor and 
Monitor 
Obligations 
The Sponsor will designate a monitor to 
conduct regular monitoring visits.  The 
purpose of these visits are to ensure the 
wellbeing of the subjects are protected 
and that data is accurate, complete and 
verifiable from source documents.   
 
The Sponsor will designate a monitor to conduct regular 
monitoring visits.  The purpose of these visits are to 
ensure that data is accurate, complete and verifiable 
from source documents.   
 
Clarification implemented 
as it is applicable for a 
retrospective study 
 
63 
End of Study 
The end of study is defined as the date 
of the last subject, last visit (LSLV).    No 
additional care for subjects will be 
provided under the protocol will be 
provided once their participation in the 
study has ended.    
Should circumstances arise which 
require the termination of the entire 
study prior to its planned completion 
The end of study is defined as the date of the last 
subject, last visit (LSLV).  No additional care for subjects 
will be provided under the protocol as this is a 
retrospective study.    
 
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 
Clarification implemented 
as it is applicable for a 
retrospective study. 

Study Protocol
Device
 
PMCF Study on PEEK Suture Anchors for Shoulder 
Indications 
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Page:  21 of 77 
 
 
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manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
SOP-059 Clinical Protocols 
 
Version  
 
Page 
Item 
Original 
New 
Reason 
(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 SOPs of the Sponsor. All 
reasonable efforts should be made to 
retain the subjects for the 12-month 
post-operative follow-up of this study.  A 
study termination CRF needs to be 
completed for any subject that does not 
complete the study, to document the 
reason for termination. 
 
site (e.g. departure of Investigator, non-compliance), then 
this will be undertaken according to the SOPs of the 
Sponsor.   
 

Study Protocol
Device
 
PMCF Study on PEEK Suture Anchors for Shoulder 
Indications 
Number: 
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Version: 2.0,  01April19 
Page:  22 of 77 
 
 
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anyone make any use of it that is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
SOP-059 Clinical Protocols 
 
Version  
 
Page 
Item 
Original 
New 
Reason 
 
63 
Revision of the 
Study Device 
If a subject has bilateral implants and 
has a revision, the subject will be 
maintained in the study and both 
implants will continue to be followed per 
the protocol visit schedule 
If a subject has bilateral implants and has a revision, 
both implants will continue to be followed per the 
protocol visit schedule. 
 
Clarification implemented 
as it is applicable for a 
retrospective study. 
 

Study Protocol
Device
PMCF Study on PEEK Suture Anchors for Shoulder 
Indications
Number:
2018.16.SMD.PEEK.RET.SHD
Version: 2.0, 01April19
Page: 23 of 77
CONFIDENTIAL AND PROPRIETARY
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intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew.
TMP-110 
Clinical Protocol - Devices 
SOP-059 Clinical Protocols
SPONSOR APPROVAL
Job title
DocuSign Stamp
Sr. Vice President, Chief 
Medical Officer, Global 
R&D
Weymann, Andy
  
Head of Global Clinical 
Strategy
    Hanson, Beate
Head of Global 
Biostatistics and Data 
Management
Rossington, Alan
Medical Affairs 
Representative
Orlandini, Luca

Study Protocol
Device
PMCF Study on PEEK Suture Anchors for Shoulder 
Indications
Number:
2018.16.SMD.PEEK.RET.SHD
Version: 2.0, 01April19
Page: 24 of 77
CONFIDENTIAL AND PROPRIETARY
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intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew.
TMP-110 
Clinical Protocol - Devices 
SOP-059 Clinical Protocols
SYNOPSIS
Title of Study:
PMCF Study on PEEK Suture Anchors for Shoulder Indications
Study Design:
Multi-center, retrospective case series.
Study Type:
Post-market Clinical Follow-up
Study Products:
PEEK Suture Anchors for Shoulder
*Part numbers as of September 2018
Healicoil PK 
Preloaded 
Suture 
Anchors
Bioraptor 2.3
PK / Bioraptor 
Curved 2.3 PK
Bioraptor 
Knotless
Suture 
Anchors
Multifix S Ultra
Knotless 
Fixation 
System
Footprint Ultra
PK Suture 
Anchor

 
Study Protocol
Device 
PMCF Study on PEEK Suture Anchors for Shoulder 
Indications 
Number:
2018.16.SMD.PEEK.RET.SHD 
Version: 2.0,  01April19
Page:  25 of 77 
 
 
CONFIDENTIAL AND PROPRIETARY 
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intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
SOP-059 Clinical Protocols 
 
 
Twinfix Ultra 
PK Suture 
Anchors / 
 
Twinfix Ultra 
Preloaded and 
with needles 
 
 
 
SpeedScrew 
 
 
 
 
SpeedLock  
 
OM-7500  SpeedLock 
 
 
Intended Use: 
The PEEK anchors are intended to be used for soft tissue to bone fixation 
in the shoulder for Bankart lesion repair, superior labral tear from anterior 
to posterior (SLAP) lesion repair, acromio-clavicular repair, capsular 

 
Study Protocol
Device 
PMCF Study on PEEK Suture Anchors for Shoulder 
Indications 
Number:
2018.16.SMD.PEEK.RET.SHD 
Version: 2.0,  01April19
Page:  26 of 77 
 
 
CONFIDENTIAL AND PROPRIETARY 
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intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
SOP-059 Clinical Protocols 
 
shift/capsulolabral reconstruction, deltoid repair, rotator cuff repair and 
bicep tenodesis. 
Study Purpose: 
Assess safety and performance post-market of the PEEK suture anchor 
devices to address clinical data gaps for MDR. 
Primary 
Outcome: 
Evidence of safety and performance of the PEEK suture anchor devices in 
the shoulder. 
Statistical 
Rationale: 
The sample size for this study is determined based on the feasibility of 
recruitment, enrolment and follow-up considerations. The study is 
therefore not powered for any statistical testing but will be able to estimate 
a clinical success rate of 91% with a 95% confidence interval (CI) of 80% t0 
100%. 
 
Sample Size: 
Minimum number of subjects, n=160 
Maximum number of subjects, n=960 
Enrollment distribution: 
Up to three sites will enroll a maximum of 40 subjects per anchor 
configuration; therefore, no more than 120 subjects will be enrolled for any 
anchor type.   
PEEK Anchor 
Minimum 
Number of 
Subjects 
Maximum  
Number of 
Subjects 
Maximum 
Number of 
Subjects for 
the Study 
Healicoil PK 
Preloaded Suture 
Anchors 
 
20 subjects per 
site 
40 subjects per 
site 
120 subjects 
Bioraptor 2.3 PK / 
Bioraptor Curved 
2.3 PK 
20 subjects per 
site 
40 subjects per 
site 
120 subjects 

 
Study Protocol
Device 
PMCF Study on PEEK Suture Anchors for Shoulder 
Indications 
Number:
2018.16.SMD.PEEK.RET.SHD 
Version: 2.0,  01April19
Page:  27 of 77 
 
 
CONFIDENTIAL AND PROPRIETARY 
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intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
SOP-059 Clinical Protocols 
 
Bioraptor 
Knotless Suture 
Anchor 
 
20 subjects per 
site 
40 subjects per 
site 
120 subjects 
Multifix S Ultra 
Knotless Fixation 
System 
 
20 subjects per 
site 
40 subjects per 
site 
120 subjects 
Footprint Ultra PK 
Suture Anchor 
 
20 subjects per 
site 
40 subjects per 
site 
120 subjects 
Twinfix Ultra PK 
Suture Anchors/ 
Twinfix Ultra 
Preloaded and 
with needles 
 
 
20 subjects per 
site 
40 subjects per 
site 
120 subjects 
SpeedScrew 
 
20 subjects per 
site 
40 subjects per 
site 
120 subjects 
SpeedLock  
 
20 subjects per 
site 
40 subjects per 
site 
120 subjects 
Total 
160 subjects 
320 subjects 
960 subjects 
 
Number of Study 
Sites: 
 Up to 16 sites 
Targeted Global 
Regions: 
USA 
Inclusion Criteria: 
1. Subjects who have undergone shoulder joint repair using the study 
devices.  
2. Subjects aged 18 years and older at the time of surgery. 

 
Study Protocol
Device 
PMCF Study on PEEK Suture Anchors for Shoulder 
Indications 
Number:
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Version: 2.0,  01April19
Page:  28 of 77 
 
 
CONFIDENTIAL AND PROPRIETARY 
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intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
SOP-059 Clinical Protocols 
 
3. Subjects must have had a visit to their provider between 3 and 15 
months post-operative. 
Exclusion 
Criteria: 
1. Subjects who are < 12 months post-operative. 
2. Subject is entered in another investigational drug, biologic, or 
device study or has been treated with an investigational product 
within 30 days prior to surgery. 
3. Off-label use of the PEEK suture anchor during surgery. 
Study Duration: 
Twelve month follow-up 
Primary Endpoint: Clinical success rate (%) at 6 months post-operative based on standard of 
care 
Secondary 
Endpoint: 
Clinical success rate (%) at 12 months post-operative based on standard of 
care. 
Exploratory 
Outcomes: 
Surgeon Reported Outcomes based on data collected on 
medical chart as standard of care at study sites. These may include but 
not restricted to the following: 
 Range of Motion (ROM)  
 Pain assessed by VAS 
 American Shoulder and Elbow Surgeons Score (ASES) 
 Oxford Shoulder Score (OSS) 
 Western Ontario Shoulder Instability Index Score (WOSI) 
Safety Endpoints: 
 All AEs, SAEs and complications including intra-operative adverse 
events and complications. 
 Device related intervention 
 Device deficiency 

Study Protocol
Device
PMCF Study on PEEK Suture Anchors for Shoulder 
Indications
Number:
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Version: 2.0, 01April19
Page: 29 of 77
CONFIDENTIAL AND PROPRIETARY
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intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew.
TMP-110 
Clinical Protocol - Devices 
SOP-059 Clinical Protocols
SCHEDULE OF EVENTS
Table 1:  Schedule of Events
Schedule of Events
Chart Review
182 days  post-op
6M (±91 Days)
365 days post-op
12M (± 91 Days )
Informed Consent 
X
NA if waiver of consent granted by IRB
Inclusion/Exclusion
X
Demographics/Medical 
History
X
VAS, ROM
X
X
Operative Data Collection
X
Implant Status and / or 
Disposition
X
X
Concomitant Medications 
or Therapies1
X
X
AE, SAE and DevD
Assessment
X
X
End of Study
X2
                                                     
1Any concomitant medications associated with an AE, SA(D)E will be recorded.
2  End of Study CRF can be completed at 6 months if the subject did not have a 12 month visit.

Study Protocol
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PMCF Study on PEEK Suture Anchors for Shoulder 
Indications
Number:
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contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew.
TMP-110 
Clinical Protocol - Devices 
SOP-059 Clinical Protocols
TABLE OF CONTENTS
Signatures............................................................................................................................. 2
1.1
Protocol Signature Page ................................................................................................ 2
Revision History, Ownership, and Approvals:....................................................................... 3
2.1
Revision History............................................................................................................. 3
Sponsor Approval ...............................................................................................................23
Synopsis ............................................................................................................................. 24
Schedule of events .............................................................................................................29
Table of Contents................................................................................................................ 30
List of Abbreviations ...........................................................................................................33
Introduction.........................................................................................................................35
8.1
Study Purpose.............................................................................................................36
8.2
Safety Considerations ................................................................................................. 36
Objective............................................................................................................................. 37
9.1
Primary Objective ........................................................................................................ 37
Study Product(s).................................................................................................................. 37
10.1
Preloaded Suture Anchors .................................................................. 37
10.2
........................................................................................................... 38
10.3
.......................................................................... 39
10.4
..............................................................40
10.5
...........................................................................40
10.6
................................................................................41
10.7
SpeedScrew ................................................................................................................ 42
10.8
SpeedLock................................................................................................................... 42
10.9
Indications...................................................................................................................43

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PMCF Study on PEEK Suture Anchors for Shoulder 
Indications
Number:
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intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew.
TMP-110 
Clinical Protocol - Devices 
SOP-059 Clinical Protocols
10.10
Product Use.................................................................................................................45
Subject Enrollment and Withdrawal ....................................................................................45
11.1
Subject Population.......................................................................................................46
11.2
Inclusion Criteria..........................................................................................................46
11.3
Exclusion Criteria.........................................................................................................46
11.4
Screening .................................................................................................................... 47
11.5
Informed Consent........................................................................................................ 47
11.6
Enrollment.................................................................................................................... 47
11.7
Lost to Follow-Up ......................................................................................................... 47
11.8
Withdrawal................................................................................................................... 48
Study Design....................................................................................................................... 48
12.1
Study Design ............................................................................................................... 48
12.2
Allocation and Blinding................................................................................................50
12.3
Study Endpoints...........................................................................................................50
Study Procedures.................................................................................................................51
13.1
6 months Post-Op Chart  Review.................................................................................51
13.2
12 months post-op Chart Review ................................................................................ 52
13.3
Concomitant Medications and Therapies....................................................................53
Statistical Design ................................................................................................................ 53
14.1
General........................................................................................................................ 53
14.2
Analysis Populations ...................................................................................................54
14.3
Efficacy Analysis .......................................................................................................... 54
14.4
Safety Analyses...........................................................................................................55
14.5
OTHER ENDPOINT Analyses........................................................................................55
Sample Size Justification .................................................................................................... 56
Adverse Events and Device Deficiencies............................................................................ 57

Study Protocol
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PMCF Study on PEEK Suture Anchors for Shoulder 
Indications
Number:
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contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew.
TMP-110 
Clinical Protocol - Devices 
SOP-059 Clinical Protocols
16.1
Definitions ................................................................................................................... 57
16.2
Reporting Procedures..................................................................................................60
Investigator Obligations ......................................................................................................63
Sponsor and Monitor Responsibilities................................................................................63
Protocol Amendments ........................................................................................................ 63
Confidentiality of the Study.................................................................................................63
Statements of Compliance..................................................................................................63
End of Study........................................................................................................................64
Revision of the Study Device ..............................................................................................64
Publication Policy ................................................................................................................65
24.1
Publication of Study Data ............................................................................................65
24.2
Data Sharing................................................................................................................65
References..........................................................................................................................66
Appendices......................................................................................................................... 67
26.1
Principal Investigator Obligations (ISO14155) .............................................................. 67
TABLES 
Table 1:  Schedule of Events..........................................................................................................29
Table 2:  Instructions for Use Reference Numbers........................................................................ 36
Table 3:  Part Numbers .................................................................................................................43
Table 4:  Enrollment.......................................................................................................................49
Table 5:  Categories of Adverse Events ........................................................................................ 57
FIGURES
Figure 1:  Evaluation and Reporting of AE and DevD .....................................................................62

Study Protocol
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PMCF Study on PEEK Suture Anchors for Shoulder 
Indications
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contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew.
TMP-110 
Clinical Protocol - Devices 
SOP-059 Clinical Protocols
LIST OF ABBREVIATIONS 
Abbreviation
Term
ABHI
Association of British Healthcare Industries
ABS
Acrylonitrile Butadiene Styrene
ADE
Adverse Device Effect(s)
AE
Adverse Event(s)
ASADE
Anticipated Serious Adverse Device Effect
CFR
Code of Federal Regulations
CI
Confidence Interval
CRF
Case Report Form(s)
CSR
Clinical Study Report
CTA
Clinical Trial Agreement
CV
Curriculum Vitae
DevD
Device Deficiency(ies)
GCP
Good Clinical Practice
HHS
Health and Human Services
ICH
International Conference on Harmonisation 
ICMJE
International Committee of Medical Journal Editors
IEC
International Ethics Committee
IFU
Instructions for Use
IP
Investigational Product
IRB
Institutional Review Board
ISF
Investigator Site File
ISO
International Organization for Standardization

 
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Indications 
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contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
SOP-059 Clinical Protocols 
 
Abbreviation 
 Term 
LSLV 
Last subject, last visit 
MDR 
Medical Device Regulation 
N (or n) 
Total Sample Size (or subgroup sample size) 
NA or N/A 
Not Applicable 
PEEK / PK 
Polyetheretherketone 
PI 
Principal Investigator 
PMCF 
Post-market Clinical Follow-up 
PP 
Per-protocol Population 
ROM 
Range of Motion 
S&N 
Smith & Nephew Inc. 
SADE 
Serious Adverse Device Effect(s) 
SAE 
Serious Adverse Event(s) 
SAF 
Safety Population 
SAP 
Statistical Analysis Plan 
SLAP 
Superior labral tear from anterior to posterior 
UHWM 
Ultra-high molecular-weight 
USADE 
Unanticipated Serious Adverse Device Effect(s) 
VAS 
Visual Analogue Scale 

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CONFIDENTIAL AND PROPRIETARY
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intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew.
TMP-110 
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INTRODUCTION
Suture anchors are small fixation devices used in surgical procedures for attaching or reattaching 
tendons and ligaments
bone density and the procedure performed.
Suture anchors are made of three components: the anchor - which is inserted into the bone; the 
eyelet which is a hole or a loop in the anchor that the suture passes through to link the anchor 
to the suture; and the suture which is attached to the anchor through the eyelet of the anchor.  
An anchor- receiving hole is first drilled in the bone at the desired point of tissue reattachment.  
A suture anchor is deployed in the hole using an appropriate installation tool.  This effectively 
locks the suture to the bone, with the free end(s) of the suture extending out the bone.  Soft 
tissue is then moved into position over the hole containing the deployed suture anchor.  As this 
is done, the free end(s) of the suture is (are) passed through or around the soft tissue so that the 
free end(s) of the suture reside(s) on the far (i.e., non-bone) side of the soft tissue.  The suture is 
now used to tie the soft tissue securely to the bone.
Smith & Nephew offers a variety of suture anchors including several polyetheretherketone (PEEK) 
suture anchors soft tissue to bone repair.  The PEEK devices included in study are all single use, 
sterile devices comprised of machined component anchor bodies that are manufactured from 
PEEK-OPTIMA Polymer (LT1).  This material meets ISO 10993 biocompatibility requirements for 
implant devices, bone/tissue contact and permanent contact.  The anchor tips are molded 
components which are also manufactured from PEEK-OPTIMA Polymer (LT3).  PEEK-OPTIMA 
polymers provide an ideal combination of strength, biocompatibility, reviseability and inherent 
radiolucent characteristics.  Smith & Nephew also provides a variety of reusable and disposable 

 
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intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
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instrumentation used in conjunction with the suture anchors including awls, dilators, drills, 
guides, obturators and wires. 
7.1 STUDY PURPOSE 
The purpose of this study is to conduct post-market clinical follow-up regarding the safety and 
performance of the PEEK anchors as required per MDR.  
7.2 SAFETY CONSIDERATIONS 
 Refer to the IFUs. 
Table 2:  Instructions for Use Reference Numbers 
 
Instructions for Use have been provided as a reference but may not have been the version used 
at the time of surgery. 
 
PEEK Suture Anchor 
IFU 
Healicoil PK Preloaded Suture Anchors 
10600803 2/17, Rev D 
Bioraptor 2.3 PK Suture Anchors 
10600304 1/17, Rev D/10600778 Rev D 
Bioraptor Curved 2.3 PK Suture Anchors 
Bioraptor Knotless Suture Anchors 
10600479 2/17, Rev E 
Multifix S Ultra Knotless Fixation System 
P/N 65101 4/17, Rev B 
Footprint Ultra PK Suture Anchors 
10600584 2/17, Rev E 
Twinfix Ultra PK Suture Anchors 
Twinfix Ultra Preloaded and with needles 
10600332 1/17, Rev E/ 
10600677 Rev C 
SpeedScrew 
P/N 62528 3/17, Rev C 
SpeedLock  
P/N 62513 8/18, Rev D 
 
 
 
 

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intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew.
TMP-110 
Clinical Protocol - Devices 
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OBJECTIVE
8.1 PRIMARY OBJECTIVE
The primary objective of this study is to assess safety and performance post-market of the PEEK 
anchor devices in the shoulder.
STUDY PRODUCT(S)
9.1   
PK PRELOADED SUTURE ANCHORS
nonabsorbable PK (PEEK-OPTIMA® from Invibio®) suture anchor with an attached non-
absorbable suture assembled to an insertion device which has a stainless steel shaft and a 
polycarbonate and acrylonitrile butadiene styrene (ABS) handle. The sutures are braided, 
uncoated, ultra-high-molecular-weight (UHMW) polyethylene and are available with up to three 
sutures. The suture anchors are intended to provide securer attachment of soft tissue to bone. The 
a distinctive open-architecture that differs from solid-core 
implants by eliminating the material between the anchor threads. The open design allows blood 
and bone marrow from surrounding cancellous bone to enter the implant. These suture anchors 
are available in 4.5mm or 5.5mm diameters.

 
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CONFIDENTIAL AND PROPRIETARY 
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intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
SOP-059 Clinical Protocols 
 
9.2   
 PK  
 
 (PEEK-OPTIMA® from Invibio®) Suture 
Anchor is a single use, sterile device intended to provide secure attachment of soft tissue to 
bone. The device consists of a suture anchor with attached non-absorbable suture(s) 
preassembled to a stainless steel insertion device that has an ABS handle. The anchor is 
preloaded with ultra-high molecular weight polyethylene No. 2 braided suture. This is the same 
  
-assembled to a 
flexible insertion device, and are designed for use with the Smith & Nephew curved guide, 
flexible obturator, and flexible drill bit. 
-in anchor that is 
manufactured from PEEK-OPTIMA® from Invibio®. The anchor is pre-assembled on an inserter 
comprised of a stainless steel shaft and an ABS and polycarbonate handle. The anchor is sized 
appropriately to facilitate both hip and shoulder procedures. The design consists of an outer 
anchor body and an inner shaft plug. The ribbed anchor, loaded with suture tails, is tapped into a 
pre-drilled prepared hole. The surgeon is now able to reapproximate the tissue to the 
appropriate tension and then use the torque limiting knob on the insertion device that moves the 
inner plug down to lock the plug and achieve a secure fixation. 

 
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CONFIDENTIAL AND PROPRIETARY 
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intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
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9.3   
 KNOTLESS SUTURE ANCHOR 
 
 
ess Suture Anchor is a single use, sterile, tap-in anchor that is manufactured 
from PEEK-OPTIMA® from Invibio®. The anchor is pre-assembled on an inserter comprised of a 
stainless steel shaft and an ABS and polycarbonate handle. The anchor is sized appropriately to 
facilitate both hip and shoulder procedures. The design consists of an outer anchor body and an 
inner shaft plug. The ribbed anchor, loaded with suture tails, is tapped into a pre-drilled prepared 
hole. The surgeon is now able to reapproximate the tissue to the appropriate tension and then use 
the torque limiting knob on the insertion device that moves the inner plug down to lock the plug 
and achieve a secure fixation. 

 
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CONFIDENTIAL AND PROPRIETARY 
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intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
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9.4   
 S ULTRA KNOTLESS FIXATION SYSTEM 
 
 
instruments that facilitate the attachment of tissue to bone. The implant, which is available in 
5.5mm and 6.5mm sizes, can accommodate 2, 3 or 4 suture strands or a maximum volume of 2 
polyetheretherketone (PEEK) and is pre-loaded onto a disposable handle designed to facilitate 
direct insertion into bone. The suture anchor is a knotless fixation device, in other words surgical 
knots are not necessary for fixation of suture to tissue. 
9.5   
 ULTRA PK SUTURE ANCHOR 
 
 
-in anchor that is manufactured 
from PEEKOPTIMA® (LT3) fro
intended to provide 
re 

 
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CONFIDENTIAL AND PROPRIETARY 
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intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
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Anchor is not preloaded with sutures but is preassembled to an insertion device comprised of a 
stainless steel shaft and ABS and polycarbonate handle and held in place with a retention suture. 
The anchor accommodates up to four 
-piece design 
of the device consists of an anchor body and an inner plug. The inner plug is rotated down into 
the internally threaded anchor body to capture the suture. 
are available in 4.5 and 5.5mm diameters. 
 
9.6   
 ULTRA PK SUTURE ANCHORS 
 
a nonabsorbable PEEK-OPTIMA® from Invibio® suture anchor and an attached non-absorbable 
suture assembled to an insertion device which has a stainless steel shaft and a polycarbonate 
and ABS handle.  The suture anchor comes with ready-to-use preloaded sutures. The device has 
a twist-and-release needle delivery system with needles provided in the ergonomically designed 
handle. Distal "cutting" threads provide eas
strong pull
Suture Anchors with Needles are available in 4.5mm, 
5.5mm and 6.5mm diameters and with up to two sutures. 

 
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intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
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9.7   SPEEDSCREW 
 
that facilitate the attachment of tissue to bone. The SPEEDSCREW implant is a knotless fixation 
device, in other words surgical knots are not necessary for fixation of suture to tissue. The 
SPEEDSCREW implant is available in two sizes, 5.5mm and 6.5mm. 
 
9.8   SPEEDLOCK 
 
 
The SpeedLock Knotless Fixation Device is an implant that facilitates the attachment of tissue to 
bone. The SpeedLock system consists of a fixation device pre-loaded with a suture snare in an 

 
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intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
SOP-059 Clinical Protocols 
 
inserter handle. The SpeedLock implant is a knotless fixation device, in other words surgical 
knots are not necessary for fixation of suture to tissue. 
9.9   INDICATIONS 
 
The Smith & Nephew PEEK anchors are intended to be used for soft tissue to bone fixation in the 
shoulder for Bankart lesion repair, superior labral tear from anterior to posterior (SLAP) lesion 
repair, acromio-clavicular repair, capsular shift/capsulolabral reconstruction, deltoid repair, 
rotator cuff repair and bicep tenodesis. 
 
Table 3:  Part Numbers 
*Part numbers as of September 2018 
 
PEEK Suture Anchors for Shoulder 
 
Healicoil PK 
Preloaded 
Suture 
Anchors 
 
Bioraptor 2.3 
PK / Bioraptor 
Curved 2.3 
PK 
 
 
 
 
Bioraptor 
Knotless 
 
 

 
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CONFIDENTIAL AND PROPRIETARY 
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intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
SOP-059 Clinical Protocols 
 
Suture 
Anchors 
Multifix S 
Ultra Knotless 
Fixation 
System 
 
 
Footprint Ultra 
PK Suture 
Anchor 
 
 
Twinfix Ultra 
PK Suture 
Anchors/ 
Twinfix Ultra 
Preloaded 
and with 
needles 
 
 
 

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intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew.
TMP-110 
Clinical Protocol - Devices 
SOP-059 Clinical Protocols
SpeedScrew
SpeedLock 
OM-7500 Speedlock
9.10  PRODUCT USE
All study related procedures using the PEEK suture anchors in the shoulder have been 
performed according to the recommended surgical technique described in the labelling and the 
instructions for use.
SUBJECT ENROLLMENT AND WITHDRAWAL
Investigators will screen all subjects that have undergone usage of the PEEK suture anchors in 
the shoulder using only the existing information in the medical records. 
Investigators will conduct a chart review after IRB approval has been granted.  All subjects whose
chart undergoes the screening process will be documented on a Screening and Enrollment Log, 
with the reason for exclusion noted, if applicable. The Investigator or designee must notify the 
Sponsor upon subject enrollment.

 
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intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
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10.1  SUBJECT POPULATION 
To minimize the potential for selection bias, Investigators will screen and subsequently enroll 
subjects (after fulfilling all inclusion and exclusion criteria) on whom PEEK suture anchors in the 
shoulder were implanted. Enrollment will be in sequential order based on the date of their 
surgical procedure with the investigational device, i.e. time of surgery to present day. 
10.2  INCLUSION CRITERIA 
Subjects will be considered qualified for enrollment if they meet the following criteria: 
1. Subjects who have undergone shoulder joint repair using the study devices.  
2. Subjects aged 18 years and older at the time of surgery. 
3. Subjects must have had a visit to their provider between 3 and 15 months post-operative. 
 
10.3  EXCLUSION CRITERIA 
Any one (1) of the following criteria will disqualify a potential subject from participation in 
the study: 
 
1. Subjects who are < 12 months post-operative. 
2. Subject is entered in another investigational drug, biologic, or device study or has been 
treated with an investigational product within 30 days prior to surgery.  
3. Off-label use of the PEEK suture anchor during surgery. 

 
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intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
SOP-059 Clinical Protocols 
 
10.4  SCREENING  
Participating study sites are required to document all screened subjects considered for inclusion 
in this study. If a subject is excluded from the study, the reasons for exclusion will be 
documented in the subject's source documents and noted on the Screening and Enrollment Log.  
10.5  INFORMED CONSENT 
For adults and children, a waiver or alteration of the requirements for obtaining informed consent 
can occur under any of the following three provisions set forth by HHS: 
Research in general: an IRB may waive or alter the requirement of informed consent under 45 
CFR 46.116(d), provided that the IRB finds and documents that all of the following four conditions 
are met: [3] 
1. the research involves no more than minimal risk to the participants; 
2. the waiver or alteration will not adversely affect the rights and welfare of the participants; 
3. the research could not practicably be carried out without the waiver or alteration; and 
4. whenever appropriate, the participants will be provided with additional pertinent information   
after participation. 
10.6  ENROLLMENT 
Enrollment in this study shall occur when subjects have meet inclusion criteria and none of the 
exclusion criteria.  When a subject is enrolled for the left shoulder as well as the right shoulder, 
only one subject ID will be allocated. 
10.7  LOST TO FOLLOW-UP 
Not applicable. 

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contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew.
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SOP-059 Clinical Protocols
10.8  WITHDRAWAL
10.8.1 Withdrawal from the Study
The Investigator may withdraw subjects from the study for many reasons, including but not limited 
to the following:
At the discretion of the Investigator.
If the Investigator or the Sponsor stops the study for any reason and decides to withdraw 
subject(s) from the study.
For each case, information will be documented in the source document and the Case Report 
Form (CRF), detailing circumstances leading to the withdrawal. 
Subjects who are withdrawn will not be re-entered into the study at a later date.  Data collected 
up to the point of withdrawal may be used but no additional data for that subject may be 
collected.
STUDY DESIGN
11.1  STUDY DESIGN
This is a retrospective, open-label, multicenter study to collect clinical data that will evaluate 
post-market safety and performance of the PEEK suture anchors in the shoulder. A minimum of 
160 subjects and maximum of 960 subjects in the United States who underwent surgery in the 
shoulder using the Smith & Nephew PEEK anchor sutures are planned to be enrolled into the 
study after the fulfillment of all inclusion and exclusion criteria. Up to three sites will enroll a 
minimum of 20 subjects and a maximum of 40 subjects per anchor configuration; therefore, no 
more than 120 subjects will be enrolled for any anchor type.  

 
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intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
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Data obtained from enrolled eligible subjects will subsequently be recorded on case report forms.  
 
Table 4:  Enrollment 
  
PEEK Anchor 
Minimum 
Number of 
Subjects 
Maximum  
Number of 
Subjects 
Maximum 
Number of 
Subjects for 
the Study 
Healicoil PK 
Preloaded Suture 
Anchors 
 
20 subjects per 
site 
40 subjects per 
site 
120 subjects 
Bioraptor 2.3 PK / 
Bioraptor Curved 
2.3 PK 
20 subjects per 
site 
40 subjects per 
site 
120 subjects 
Bioraptor 
Knotless Suture 
Anchor 
 
20 subjects per 
site 
40 subjects per 
site 
120 subjects 
Multifix S Ultra 
Knotless Fixation 
System 
 
20 subjects per 
site 
40 subjects per 
site 
120 subjects 
Footprint Ultra PK 
Suture Anchor 
 
20 subjects per 
site 
40 subjects per 
site 
120 subjects 
Twinfix Ultra PK 
Suture Anchors/ 
Twinfix Ultra 
20 subjects per 
site 
40 subjects per 
site 
120 subjects 

 
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contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
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Preloaded and 
with needles 
 
 
SpeedScrew 
 
20 subjects per 
site 
40 subjects per 
site 
120 subjects 
SpeedLock  
 
20 subjects per 
site 
40 subjects per 
site 
120 subjects 
Total 
160 subjects 
320 subjects 
960 subjects 
 
 
 
11.2  ALLOCATION AND BLINDING 
This study is not randomized or blinded. 
11.3  STUDY ENDPOINTS 
11.3.1 Primary Endpoint 
The primary endpoint will be clinical success rate (%) at 6 months post-operative based on 
standard of care. Clinical success is defined as shoulder repairs without signs of device failure 
and/or re-intervention as assessed by the surgeon. 
11.3.2 Secondary Endpoints  
The secondary endpoint will be clinical success rate (%) at 12 months post-operative based on 
standard of care.  Clinical success has previously been defined.  It is expected that per 
may not be available for all subjects. 

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contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew.
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11.3.3
Safety Endpoints
Safety endpoints will include but not restricted to the following events:
All adverse events, SAEs and complications occurring from the time of enrollment until 
study termination or study completion including intra-operative adverse events and 
complications.
Device related intervention.
Device deficiency.
11.3.4
Other Endpoints
Surgeon Reported Outcomes would constitute other endpoints and may include but not 
restricted to the following:
Range of Motion (ROM) 
Pain assessed by VAS
American Shoulder and Elbow Surgeons Score (ASES)
Oxford Shoulder Score (OSS)
Western Ontario Shoulder Instability Index Score (WOSI)
STUDY PROCEDURES
12.1  6 MONTHS POST-OP CHART  REVIEW
NOTE: Any subject, who meets the inclusion/exclusion criteria, will be assigned a subject 
number.

 
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intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
SOP-059 Clinical Protocols 
 
1. Subject should undergo the informed consent process and sign the informed consent 
only if a waiver of consent has not been approved by the IRB. 
2. 
ol inclusion/exclusion criteria.   
3. Obtain demographic information and a medical history. 
4. VAS, ROM. 
5. Operative Data Collection  review operative case notes. 
6. Implant Status /Disposition. 
7. Document concomitant medications and/or therapies associated with an AE, SA(D)E. 
8.  
-
operative.  AEs, SAEs and DevDs should be documented from the time of surgery through 
the study duration. 
12.2  12 MONTHS POST-OP CHART REVIEW 
1.  VAS, ROM. 
2. Implant Status/Disposition. 
3. Document concomitant medications and/or therapies associated with an AE, SA(D)E. 
4. Review th
s, SAEs and Device Deficiencies including inter-operative.  
AEs, SAEs and DevDs should be documented from the time of surgery through the study 
duration. 
5. Complete the End of Study CRF. 

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CONFIDENTIAL AND PROPRIETARY
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew.
TMP-110 
Clinical Protocol - Devices 
SOP-059 Clinical Protocols
12.3  CONCOMITANT MEDICATIONS AND THERAPIES
Any concomitant medications associated with an AE, SAE or SADE will be recorded.  Concomitant 
visit occurred at 6 months, concomitant medications will be collect through 6 months.
STATISTICAL DESIGN
A Statistical Analysis Plan (SAP) will be written and finalized prior to database lock. The analyses 
specified in the protocol will be a microcosm of the detailed analyses to be contained in the SAP.
If there are changes to or additional analyses required to the analysis described below, it will be 
described in the SAP and the Clinical Study Report (CSR). 
13.1  GENERAL
or designee will conduct the statistical analysis for 
this study. Unless otherwise stated, all significance tests will be two-sided, performed at the 5% 
significance level. Resulting p-values will be provided and 95% two-sided confidence intervals 
will be generated where appropriate. 
Where data summaries are specified, categorical and ordinal variables will be summarized with 
frequencies and percentages. Continuous variables will be summarized with the following 
summary statistics: number of observations, mean, median, standard deviation, minimum and 
maximum values. All analyses will be performed in SAS version 9.3 (or later).

 
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CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
SOP-059 Clinical Protocols 
 
13.2  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 shoulder repair using PEEK suture anchors, i.e. subjects who would 
provide retrospective data.  
 Per-Protocol Population (PP): This includes all subjects in the Safety Population, who 
have no significant protocol deviations and who meet all the inclusion/exclusion criteria. 
13.3  EFFICACY ANALYSIS 
13.3.1 Analysis of Primary Endpoint 
The rate (%) of clinical success of all the PEEK suture anchor devices combined at 6 months post-
operative will be summarized as a frequency and percentage.  A 95% two-sided exact CI for a 
single proportion will be presented using Clopper-
 [1]. The same type analysis 
would be carried out for each of the different types of PEEK suture anchors used in the study.  
These analyses will be carried out using the per protocol population as the primary analysis 
population, with the safety population used for sensitivity analysis.  
13.3.2 
Analysis of Secondary Endpoints 
The analysis of the following secondary endpoint will be carried out using the safety population.  
o The rate (%) of clinical success of all the PEEK suture anchors combined at 12 months 
post-operative  will be summarized as described for the analysis of the primary endpoint.  

 
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CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
SOP-059 Clinical Protocols 
 
This analysis will also be repeated for each of the different types of PEEK suture anchors 
used in the study.   
13.4  SAFETY ANALYSES 
o All safety endpoints will be summarized using the safety population. The incidence of 
events encountered on-study will be summarized using frequencies and percentages.  
An overall AE table will be summarized using the overall incidence according to subjects 
with at least one AE; subjects with at least one AE by worst severity (mild, moderate, or 
severe); subjects with at least one AE by worst outcome; subjects with one AE that led to 
study discontinuation; subjects with at least one AE by relatedness to investigational 
device; SAEs; ADEs; ASADEs; USADEs and; SADEs as applicable.  A cumulative summary 
by the number of events encountered within each classification will also be summarized. 
The incidence of subjects reporting device deficiencies will additionally be summarized. 
o Each of the AE classifications will further be summarized by event using the frequencies 
(n) and percentages (%) of subjects with each event as well as the ccumulative 
events/episodes per event.  
o A listing of concomitant medications will be provided by subject. 
Additional summaries of safety endpoints, if applicable, will be described in the SAP. 
13.5  OTHER ENDPOINT ANALYSES 
o The analyses of other endpoints will be carried out using the safety population. Overall 
device-related failure and device-related re-intervention encountered on-study will be 
summarized independently as frequencies and percentages.  A 95% two-sided exact CI 

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intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew.
TMP-110 
Clinical Protocol - Devices 
SOP-059 Clinical Protocols
for a single proportion will be presented for each proportion using Clopper-
s 
method (1).
o
The derivation of surgeon reported outcomes used in summarizing this data for the study 
will be described in the SAP and will be summarized as appropriate using descriptive 
summary characteristics for continuous or categorical endpoints at 6 months and 12 
months.
13.6  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. 
The sample size for this study is determined based on the feasibility of recruitment, enrollment 
and follow-up considerations. The study is therefore not powered for any statistical testing but 
will be able to estimate a clinical success rate of 91% with a 95% confidence interval (CI) of 80% 
to 100%.
With an assumption of a 91% clinical success rate to be obtained in each of the PEEK anchor 
sutures and a corresponding 95% CI between 80% and 100%, enrolling between 20 and 120
subjects for each PEEK anchor suture
precision analysis will provide between 15.2% to >95% 
probability.  Thus, an overall minimum of 160 and maximum of 960 subjects who had previously 
undergone surgery of the shoulder using PEEK anchor sutures will be enrolled into the study.
Additionally, a minimum of 20 subjects will be enrolled at any investigational site. 

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CONFIDENTIAL AND PROPRIETARY
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intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew.
TMP-110 
Clinical Protocol - Devices 
SOP-059 Clinical Protocols
ADVERSE EVENTS AND DEVICE DEFICIENCIES
15.1  DEFINITIONS
The categories of adverse events are shown in Table 2. The definitions for each of these 
categories are given in the subsequent sections (see reference within the table).  All adverse 
events will be captured from the time of surgery through the 12 month follow-up visit.
Table 5:  Categories of Adverse Events
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)
ANTICIPATED
UNANTICIPATED
ANTICIPATED SERIOUS 
ADVERSE DEVICE EFFECT 
(ASADE)
UNANTICIPATED SERIOUS 
ADVERSE DEVICE EFFECT  
(USADE)
15.1.1 Adverse Event
An Adverse Event (AE) is any untoward medical occurrence temporally associated with the use of 
an IP/Ancillary Product, whether or not considered causally related to that IP/Ancillary Product.

 
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intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
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TMP-110  Clinical Protocol - Devices  
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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.  
15.1.2 Adverse Device Effect 
An Adverse Device Effect (ADE) is an adverse event that, in the opinion of the investigator, is 
related to the IP or the procedure.  
Not Related -  An AE is considered to be not related to the use of an IP or the procedure when 
the effect is DEFINITELY UNRELATED or UNLIKELY to have any relationship to the 
use of the IP or the procedure. 
Related   An AE is considered to be related to the use of an IP or the procedure when there is a 
POSSIBLE, PROBABLE, or DEFINITE relationship between the AE and the use of the IP 
or the procedure. 
15.1.3 Serious Adverse Events and Serious Adverse Device Effects  
An AE or ADE is considered a Serious Adverse Event (SAE) or Serious Adverse Device Effects 
(SADE) if, in the view of either the Investigator or the Sponsor, it: 
 Results in death. 

 
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intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
SOP-059 Clinical Protocols 
 
 Is life-threatening (NOTE
-
to an event/reaction in which the subject was at risk of death at the time of the 
event/reaction; it does not refer to an event/ reaction which hypothetically might have 
caused death if it were more severe). 
 Requires in subject hospitalization or results in prolongation of existing hospitalization. 
 Results in persistent or significant incapacity or substantial disruption of the ability to 
conduct normal life functions. 
 Is a congenital anomaly/birth defect. 
 Is a medically important event or reaction. 
Medical and scientific judgment should be exercised in deciding whether other situations should 
be considered serious such as important medical events that might not be immediately life 
threatening or result in death or hospitalization but might jeopardize the subject or might require 
intervention to prevent one of the other outcomes listed in the definition above. Examples of such 
events are intensive treatment in an emergency room or at home for allergic bronchospasm, 
blood dyscrasias, or convulsions that do not result in hospitalization, or development of drug 
dependency or drug abuse. 
15.1.4 Anticipated/Unanticipated Serious Adverse Device Effect 
An Unanticipated Serious Adverse Device Effect (USADE) is a serious ADE that meets any of the 
above definitions but is also considered, by the Investigator, to be caused by or related to the IP, 
not previously identified in nature, severity or degree in the IFU.    
 

 
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intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
SOP-059 Clinical Protocols 
 
An Anticipated Serious Adverse Device Effect (ASADE) is a serious ADE that does not meet the 
criteria for a USADE.  
15.1.5 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 
 
Severe -    
An event is severe if the sign or symptom is incapacitating and results in the 
inability to work or engage in their usual activities. 
15.1.6 Device Deficiency 
A Device Deficiency (DevD) is an inadequacy of a medical device with respect to its identity, 
quality, durability, reliability, safety or performance. DevD includes malfunctions, use errors and 
inadequate labelling.  
15.2  REPORTING PROCEDURES 
AE of any kind and DevD will be recorded in the applicable CRF and source notes. The 
Investigator will evaluate all AE for relationship to the device and procedure, if applicable, 

 
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intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
SOP-059 Clinical Protocols 
 
seriousness, and severity. ADE, SAE, and DevD will be entered into the CRF and reported to the 
Sponsor within 24 hours of the investigator being informed about the event (Figure 1).   
Applicable to the retrospective study design, 24 hour reporting begins at the time the 
Investigator was informed of the event under the auspice of the clinical study.  For ADE and 
DevD, details of the product/procedure related to the event will be included and where 
applicable and available, pictures taken of the device.  If available, the deficient product should 
be retained for return to S&N unless it is contaminated (e.g. used dressings must not be 
retained).  
 
All SAE and ADE will be reviewed by a medically qualified person appointed by the Sponsor to 
determine which, if any, meet criteria for expedited reporting to the regulatory authorities.  The 
investigator will inform the IRB/IEC of adverse events according to the IRB/IEC requirements. 
Depending on the nature of the adverse event, S&N 
records, imaging, operative notes, as well as results of any relevant laboratory tests performed or 
other documentation related to the AE. If the subject was hospitalized, a copy of the discharge 
summary may be requested by S&N and should be forwarded as soon as it becomes available. 
In certain cases, S&N also may request a letter from the Investigator that summarizes the events 
related to the case. 
 
 
 
 
[Intentionally Left Blank] 

 
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intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
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TMP-110  Clinical Protocol - Devices  
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Figure 1:  Evaluation and Reporting of AE and DevD 
 
 
 
 
Reference the ISF Sponsor Contact Information Sheet to report SAE, unanticipated ADE and 
SADE, anticipated SADE, and DevD. 
 

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contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew.
TMP-110 
Clinical Protocol - Devices 
SOP-059 Clinical Protocols
INVESTIGATOR OBLIGATIONS
The Principal Investigator will comply with the commitments outlined in the Statement of 
Investigator, provided by the Sponsor, and with Good Clinical Practice (GCP), and all applicable 
regulatory requirements as outlined in Section 26.1 of this protocol.
SPONSOR AND MONITOR RESPONSIBILITIES
The Sponsor will designate a monitor to conduct regular monitoring visits.  The purpose of these 
visits are to ensure that data is accurate, complete and verifiable from source documents.  
PROTOCOL AMENDMENTS
Amendments should be made only in exceptional cases once the study has started. Protocol 
amendments must be approved by the protocol signatories prior to submission to the IRB.  
Protocol amendments need to be approved by the IRB and Regulatory Authority (ies), as 
applicable prior to implementation at the site.
CONFIDENTIALITY OF THE STUDY
The confidentiality of this study and associated documents is governed by the terms of the 
Clinical Trial Agreement (CTA).
STATEMENTS OF COMPLIANCE
This clinical study will be performed in compliance with the ethical principles of the Declaration of 
Helsinki; ISO 14155: Clinical investigation of medical devices
Good Clinical Practice and ICH-E6.

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intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew.
TMP-110 
Clinical Protocol - Devices 
SOP-059 Clinical Protocols
This clinical study will not commence until the required approval/favorable opinion from the IRB
or regulatory authority has been obtained. Any additional requirements imposed by the IRB or 
regulatory authority will be followed. 
Public/Products Liability Insurance has been purchased by Smith & Nephew plc. Worldwide and 
incorporates coverage for personal injury in respect of clinical studies. The Sponsor agrees to 
operate in good faith and in accordance with ABHI (Association of British Healthcare Industries) 
guidelines regarding compensation for injury arising in the course of clinical studies.
END OF STUDY
The end of study is defined as the date of the last subject, last visit (LSLV).  No additional care for 
subjects will be provided under the protocol as this is a retrospective study.   
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 SOPs of the Sponsor.
REVISION OF THE STUDY DEVICE
If a subject has bilateral implants and has a revision, both implants will continue to be followed
per the protocol visit schedule.

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intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew.
TMP-110 
Clinical Protocol - Devices 
SOP-059 Clinical Protocols
PUBLICATION POLICY
23.1  PUBLICATION OF STUDY DATA
The preparation and submission for publication of manuscripts containing the study results shall 
be in accordance with a process determined by the Clinical Trial Agreements between the study 
Sponsor and participating institutions. The publication or presentation of any study results shall 
comply with all applicable privacy laws, including, but not limited to the Health Insurance 
Portability and Accountability Act of 1996.
23.2  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
[2]. 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 9 months and end 36 months after article publication. Data 
supplied may only be used by the researcher(s) named in the approved research proposal for 
the purposes of achieving the aims of the analyses specified therein. All proposals should be 
directed to datasharing.gcs@smith-nephew.com. To gain access, data requestors will need to 
sign a data access agreement.

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CONFIDENTIAL AND PROPRIETARY
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intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew.
TMP-110 
Clinical Protocol - Devices 
SOP-059 Clinical Protocols
REFERENCES
1.
Clopper, CJ & Pearson ES. (1934) The use of confidence or fiducial limits illustrated in the 
case of the binomial. Biometrika, 26, 404 413.
2. Taichman, DB, et al. Data Sharing Statements for Clinical Trials: A Requirement of the 
International Committee of Medical Journal Editors. Ann Intern Med. 2017. 6th June. 
doi:10.7326/M17-1028

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intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew.
TMP-110 
Clinical Protocol - Devices 
SOP-059 Clinical Protocols
APPENDICES
25.1  PRINCIPAL INVESTIGATOR OBLIGATIONS (ISO14155)
1.
General: 
a.
The role of the PI is to implement and manage the day-to-day conduct of the clinical 
investigation as well as ensure data integrity and the rights, safety, and well-being of 
the subjects involved in the clinical investigation. 
2. Qualification of the PI. The PI shall:
a.
be qualified by education, training, and experience to assume responsibility for the 
proper conduct of the clinical investigation in accordance with this International 
Standard; evidence of such qualifications of the PI and key members of the investigation 
site team shall be provided to the Sponsor through up-to-date Curriculum Vitae (CV) or 
other relevant documentation,
b.
be experienced in the field of application and trained in the use of the investigational 
device under consideration,
c.
disclose potential conflicts of interest, including financial, that interfere with the conduct 
of the clinical investigation or interpretation of results, and
d.
be knowledgeable with the method of obtaining informed consent.
3. Qualification of investigation site. The PI shall be able to demonstrate that the proposed 
investigation site:
a.
has the required number of eligible subjects needed within the agreed recruitment 
period, and

 
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TMP-110  Clinical Protocol - Devices  
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b. has one or more qualified investigators, a qualified investigation site team and adequate 
facilities for the foreseen duration of the clinical investigation. 
4. Communication with the IEC. The PI shall:  
a. provide the Sponsor with copies of any clinical-investigation-related communications 
between the PI and the IEC, 
b. comply with the requirements described in 4.5 of ISO 14155: 
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 
, 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 

 
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CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
SOP-059 Clinical Protocols 
 
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. 
safety, and well-being or scientific integrity of the clinical investigation 
3. Approval for resumption of a suspended clinical investigation if applicable.  
c. 
obtain the written and dated approval/favorable opinion of the IEC for the clinical 
investigation before recruiting subjects and implementing all subsequent amendments, 
if required, 
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: 

 
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CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
SOP-059 Clinical Protocols 
 
i. 
Informed consent shall be obtained in writing from the subject and the process 
shall be documented before any procedure specific to the clinical investigation is 
applied to the subject; except when special circumstances for emergency 
treatments apply (see below) 
ii. 
The informed consent form consists of an information form and informed consent 
signature form. These two forms can either be combined in one document or 
separated into two documents 
b. Process of obtaining informed consent. The general process for obtaining informed 
consent shall be documented in the protocol and shall comply with the following. These 
legally authorized representative:  
i. 
Ensure that the PI or his/her authorized designee conducts the informed consent 
process 
ii. 
decision to participate throughout the clinical investigation 
iii. 
Avoid any coercion or undue improper influence on, or inducement of, the subject 
to participate 
iv. 
 
v. 
Use native non-technical language that is understandable to the subject 
vi. 
Provide ample time for the subject to read and understand the informed consent 
form and to consider participation in the clinical investigation 
vii. 
Include personally dated signatures and the PI or an authorized designee 
responsible for conducting the informed consent process 

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

 
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CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
SOP-059 Clinical Protocols 
 
1. 
For clinical investigations involving emergency treatments, when prior 
representative, if present, shall be requested.  
2. When it is not possible to obtain prior informed consent from the subject, and 
may still be enrolled if a specific process has been described in the protocol.  
3. Arrangements shall be made to inform the subject or legally authorized 
representative
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 

 
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CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
SOP-059 Clinical Protocols 
 
authorized 
representative): 
i. 
Description and purpose 
ii. 
Potential benefits 
iii. 
Risks and inconveniences or the subject and, when applicable, for any embryo, 
foetus or nursing infant 
iv. 
Alternative procedures 
v. 
Confidentiality 
vi. 
Compensation 
vii. 
Anticipated expenses, if any, to be borne by the subject for participating in the 
clinical investigation 
viii. 
Information on the role of Sponsor
 
ix. 
Contact persons 
x. 
Statement declaring that new findings or the reasons for any amendment to the 
le to 
the subject.  
xi. 
 
xii. 
Termination procedures 
f. 
Informed consent signature shall contain the following:  
i. 
The voluntary agreement to participate in the clinical investigation and follow the 
 
ii. 
A statement declaring that refusal of participation incurs no penalty for the subject 

 
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CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
SOP-059 Clinical Protocols 
 
iii. 
A statement declaring that discontinuation at any time incurs no penalty for the 
subject 
iv. 
A statement with regard to the possible consequences of withdrawal 
v. 
An acknowledgement of the information provided and confirmation that all the 
 
vi. 
A statement confirming that the subject or his/her legally authorized 
purpose of the clinical investigation 
vii. 
A statement confirming that the subject or his/her legally authorized 
representative agrees that Sponsor
IEC 
 
g. New information: if new information becomes available that can significantly affect a 
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, 

 
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CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
SOP-059 Clinical Protocols 
 
c. 
create and maintain source documents throughout the clinical investigation and make 
them available as requested during monitoring visits or audits, 
d. ensure that the investigational device is used solely by authorized users as specified in 
6.2, and in accordance with the protocol and instructions for use, 
e. propose to the Sponsor any appropriate modification(s) of the protocol or investigational 
device or of the use of the investigational device, 
f. 
refrain from implementing any modifications to the protocol without agreement from the 
Sponsor, IEC and regulatory authorities, if required, 
g. document and explain any deviation from the approved protocol that occurred during 
the course of the clinical investigation, 
h. ensure that an adequate investigation site team and facilities exist and are maintained 
and documented during the clinical investigation, 
i. 
ensure that maintenance and calibration of the equipment relevant for the assessment 
of the clinical investigation is appropriately performed and documented, where 
applicable, 
j. 
ensure the accuracy, completeness, legibility and timeliness of the data reported to the 
Sponsor in the CRF and in all required reports, 
k. maintain the device accountability records, 
l. 
allow and support the Sponsor to perform monitoring and auditing activities, 
m. be accessible to the monitor and respond to questions during monitoring visits, 
n. allow and support regulatory authorities and the IEC when performing auditing activities, 
o. ensure that all clinical-investigation-related records are retained as required taking 
measures to prevent accidental or premature destruction, and 

 
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CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110  Clinical Protocol - Devices  
SOP-059 Clinical Protocols 
 
p. review and sign the clinical investigation report, as applicable. 
7. Medical care of subjects. The Principal Investigator shall 
a. provide adequate medical care to a subject during and after a subject's participation in 
a clinical investigation in the case of adverse events,  
b. inform the subject of the nature and possible cause of any adverse events experienced, 
c. 
provide the subject with the necessary instructions on proper use, handling, storage, 
and return of the investigational device, when it is used or operated by the subject, 
d. inform the subject of any new significant findings occurring during the clinical 
investigation, including the need for additional medical care that may be required, 
e. provide the subject with well-defined procedures for possible emergency situations 
related to the clinical investigation, and make the necessary arrangements for 
emergency treatment, including decoding procedures for blinded/masked clinical 
investigations, as needed, 
f. 
ensure that clinical records are clearly marked to indicate that the subject is enrolled in 
a particular clinical investigation, 
g. if appropriate, subjects enrolled in the clinical investigation shall be provided with some 
means of showing their participation in the clinical investigation, together with 
identification and compliance information for concomitant treatment measures (contact 
address and telephone numbers shall be provided), 
h. inform, with the subject's approval or when required by national regulations, the 
subject's personal physician about the subject's participation in the clinical 
investigation, and  

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