Post-market Clinical Follow-up Study to Collect Safety, Performance and Clinical Data of the EZPass Suture Passer (Instrumentation) and Precision Flexible Reamers (Instrumentation)- A Retrospective Consecutive Series Study
Conditions: Anterior Cruciate Ligament Injury, Rotator Cuff Tear
Sponsor: Zimmer Biomet

 
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Post-market Clinical Follow-up Study to Collect Safety, 
Performance and Clinical Data of the EZ Pass Suture 
Passer (Instrumentation) and Precision Flexible Reamers 
(Instrumentation) 
A Retrospective Consecutive Series Study 
MDR- EZ Pass Suture Passer and Precision Flexible Reamers 
MDRG2017-89MS-32SM  
Version 4.1 
27 Apr 2021 
Region: Americas 
STUDY SPONSOR 
Zimmer Biomet 
Clinical Affairs Department 
1800 West Center Street 
Warsaw, IN 46580 
800-613-6131 
 
CONFIDENTIAL - This document contains confidential information belonging to Zimmer Biomet 
except as otherwise agreed to in writing, by accepting or reviewing this document, you agree to hold 
this information in confidence and not distribute or disclose it to others (except where required by  
applicable law) or use it for unauthorized purposes.  In the event of any actual or suspected breach 
of this obligation, Zimmer Biomet must be promptly notified.  Duplication and distribution of this 
document in any form or shape requires prior approval from Zimmer Biomet. 
 

 
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Table of Contents 
I. 
Contact Information/List of Investigators .................................................................................. 3 
II. 
Abbreviations ........................................................................................................................... 4 
III. 
Study Synopsis ........................................................................................................................ 5 
IV. 
Data Collection Overview ......................................................................................................... 7 
V. 
Introduction and Purpose ......................................................................................................... 7 
VI. 
Study Objectives ...................................................................................................................... 7 
VII. 
Study Design and Endpoints .................................................................................................... 7 
VIII. 
Study Population ...................................................................................................................... 8 
IX. 
Study Device Information ......................................................................................................... 9 
X. 
Study Procedures .................................................................................................................. 10 
XI. 
Reporting ............................................................................................................................... 12 
XII. 
Safety Management – Medical Events/Adverse Events ......................................................... 16 
XIII. 
Monitoring .............................................................................................................................. 19 
XIV. Risk Analysis ......................................................................................................................... 20 
XV. 
Statistical Methods ................................................................................................................. 20 
XVI. Quality Control & Quality Assurance ...................................................................................... 21 
XVII. Suspension or Premature Termination of the Clinical Investigation ........................................ 21 
XVIII. Amendments to the Clinical Investigation Plan ....................................................................... 21 
XIX. Publication Policy ................................................................................................................... 21 
XX. 
Document History .................................................................................................................. 22 
XXI. References ............................................................................................................................ 23 
Appendix A: SKUs and Descriptions ................................................................................................ 24 
 
  
 
 
 

 
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I. 
Contact Information/List of Investigators 
Title 
Post-market Clinical Follow-up Study to Collect Safety, 
Performance and Clinical Data of the EZ Pass Suture Passer 
(Instrumentation) and Precision Flexible Reamers 
(Instrumentation) 
Protocol Number 
MDRG2017-89MS-32SM 
Study Sponsor Contact 
Information 
Zimmer Biomet, Clinical Affairs Dept. 
1800 W. Center St, Warsaw, IN 46580 
Phone: (800) 613-6131, Fax: (574) 372-4710 
Monitoring Contact 
Information 
Zimmer Biomet, Clinical Affairs Dept. 
1800 W. Center St, Warsaw, IN 46580 
Phone: (800) 613-6131, Fax: (574) 372-4710 
Investigational Site Information 
(Clinical Investigation as per 
Annex XV of EU MDR) 
The study will include a single site.  Details regarding the site 
involved will be maintained in the Sponsor’s Trial Master File. 
External Organizations, if 
applicable 
N/A  
 
 
 

 
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II. 
Abbreviations 
ADE- Adverse Device Effect 
AE- Adverse Event 
ASADE- Anticipated Serious Adverse Device Effect 
CE- Conformité Européene 
CFR- Code of Federal Regulations 
CRF- Case Report Form 
CTA- Clinical Trials Agreement 
DD- Device Deficiency 
DoH- Declaration of Helsinki 
EC – Ethics Committee 
EDC- Electronic Data Capture 
EPR- Expected Performance Rate 
EU- European Union 
FDA- Food and Drug Administration 
HIPAA- Health Information Portability and Accountability Act 
ICF- Informed Consent Form 
IFU- Instructions For Use 
IRB- Institutional Review Board 
ISO- International Organization for Standardization 
MDR- Medical Device Regulation 
PHI- Protected Health Information 
PMCF- Post Market Clinical Follow-Up 
SADE- Serious Adverse Device Effect 
SAE- Serious Adverse Event 
USADE- Unanticipated Serious Adverse Device Effect 

 
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III. 
Study Synopsis 
Title 
Post-market Clinical Follow-up Study to Collect Safety, 
Performance and Clinical Data of the EZ Pass Suture Passer 
(Instrumentation) and Precision Flexible Reamers 
(Instrumentation) 
Protocol Number 
MDRG2017-89MS-32SM 
Sponsor 
Zimmer Biomet 
1800 W. Center St, Warsaw, IN 46580, United States 
Manufacturer 
Biomet Sports Medicine 
56 East Bell Drive, PO Box 587, Warsaw, IN  46581  USA 
Study Device(s) 
EZ Pass Suture Passers (Instrumentation) and Precision 
Flexible Reamer (Instrumentation)  
See appendix for specific SKUs and descriptions 
Study Objectives/Endpoints 
The objective of this study is to confirm the safety and 
performance of the EZPass Suture Passer Instrumentation 
and the Precision Flexible Reamer Instrumentation.  
Ultimately, clinical performance will be assessed 
retrospectively through survey questions that evaluate the 
safety and performance of these instruments.  
 
The primary objective of the study is to confirm the safety and 
clinical performance of the EZPass Suture Passer and the 
Precision Flexible Reamer Instrumentation.  
Indications/Target population 
All subjects were operated on with either the EZPass Suture 
Passer or the Precision Flexible Reamer Instrumentation will 
be considered for enrollment. Inclusion Exclusion criteria are 
based on the indications and contraindications in the 
Instructions for Use (IFU). The instruments included in the 
study were used in accordance with their IFU and Zimmer 
Biomet’s approved labeling. 
Inclusion/Exclusion criteria 
Inclusion Criteria: 
• 
EZ Pass Suture Passer: Intended as an open or 
arthroscopic instrument utilized in conjunction with a 
nitinol wire or nylon monofilament to aid in passing 
suture through soft tissue. 
• 
Precision Flexible Reamer: This device is a hand held, 
or hand-manipulated device, intended to be used in ACL 
and PCL reconstruction surgeries and is intended for 
medical purposes to manipulate tissue, or for use with 
other devices in these surgeries. 
• 
Patient must be 18 years of age or older.  
 

 
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Exclusion Criteria: 
• 
Any use other than the approved uses indicated in the 
Instructions for Use (IFU).  
Study Design 
Retrospective, Single-Center, Non-Randomized, Non-
Controlled, Single Cohort Study, Survey 
Clinical Phase 
Post-Market Clinical Follow-Up (PMCF) 
Sample Size  
A minimum of 51 enrolled subjects were operated on with the 
EZ Pass Suture Passer Instrumentation and a minimum of 51 
enrolled subjects were operated on with the Precision Flexible 
Reamer Instrumentation.  However, overall subject enrollment 
will not exceed 102. 
Length of Study 
24 months overall: 
1. IRB/Ethics Committee approval if applicable, patients’ 
identification and enrollment into the study.  
2. Collection of baseline information.  
3. Conduct data analysis, and draft the final report. 
Materials and Methods 
Clinical records of these patients will be studied from the Clinic 
database. The following information will be provided: 
• 
Instrument details for each case, descriptions will be 
documented. 
• 
Detailed complications summary; including date of 
occurrence, treatment and outcome/resolution. 
• 
Surgery/exam dates 
Data Collection 
Electronic or Hard Copy Case Report Forms 
Statistical Reporting 
Descriptive summaries will be used to generate an overall 
summary of clinical evaluation of the EZ Pass Suture Passer 
instrumentation and Precision Flexible Reamer 
instrumentation. 
Scores/Performance 
Assessments 
Survey/Operative Info/Complications 
Standards 
The PMCF is compliant with the below: 
• 
ISO 14155: 2020 - Clinical investigation of medical 
devices for human subjects - Good clinical practice.[1] 
• 
The Declaration of Helsinki (DoH) - Ethical principles 
for medical research involving human subjects.[2] 
Study Funding 
Funding for this clinical study is made available by Zimmer 
Biomet to support clinical data collection, IRB/EC review fees 
and other expenses associated with the conduct and 
execution of this study protocol as outlined in the fully 
executed Clinical Trial Agreement. 
 

 
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IV. 
Data Collection Overview 
The following table indicates the necessary Case Report Forms to be completed 
at each given time point: 
Form 
Baseline 
 
Pre-Operative 
Post-Operative 
Patient Information and 
Informed Consent,  
Inclusion/Exclusion Criteria,  
Demographic Evaluation  
X 
 
Operative Information/Surgical 
Device Information 
 
X 
Complications/Adverse Events 
As required 
As required 
 
V. 
Introduction and Purpose 
The aim of this retrospective post-market follow-up study is to evaluate the safety 
and performance results of the EZPass Suture Passer and Precision Flexible 
Reamer Instrumentation. Both of these instruments are CE marked in Europe and 
FDA cleared. The EZ Pass Suture Passer has been CE-marked in Europe since 
2015. The Precision Flexible Reamer has been CE-marked in Europe since 2013. 
VI. 
Study Objectives 
The primary objective of the study is to confirm the safety and clinical 
performance of the EZPass Suture Passer and the Precision Flexible Reamer 
Instrumentation.  
Performance will be assessed through a post-operative survey conducted up to 
14 days post-operatively.  
Safety will be assessed by recording and analyzing the incidence and frequency 
of complications, adverse events, and intra-operative revisions. 
VII. Study Design and Endpoints 
Study Design 

 
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This is a single-center, retrospective enrollment, non-randomized, non-controlled, 
consecutive series post-market clinical follow-up study. The intent of the study is 
that subjects who have already had the surgical instrumentation used will be 
retrospectively enrolled in the study and data will be collected post-operatively. 
Subjects treated with the device will be identified and invited to participate in the 
study. Up to 102 subjects (51 subjects per arm of the study) will be enrolled into 
the study. This study will be conducted in the United States.  
The study duration is dependent upon available retrospective data from the site 
and corresponds to time dedicated to: 
• Obtain the Institutional Review Board (IRB)/Ethics Committee (EC) approval. 
• Identify, obtain verbal or written informed consent, and retrospectively enroll 
subjects into the study. 
• Collect baseline information available in medical records from the pre-
operative interval to the post-op evaluation. 
• Conduct data collection and analysis 
• Draft the final report 
Primary Outcome Measures/Endpoints 
The primary endpoint for this study is the evaluation of the instrumentation safety 
from the results of the frequency of complications and adverse events from the 
time of admission until the time of follow-up post-operatively. The performance of 
the instrumentation will also be evaluated and collected in the form of an operative 
survey.  
VIII. Study Population 
The study population should be a consecutive series of subjects where the 
EZPass Suture Passer or Precision Flexible Reamer instrumentation was used. 
The following inclusion and exclusion criteria will be considered: 
 
Inclusion Criteria 
• EZ Pass Suture Passer: Intended as an open or arthroscopic instrument 
utilized in conjunction with a nitinol wire or nylon monofilament to aid in 
passing suture through soft tissue. 
• Precision Flexible Reamer: This device is a hand held, or hand-manipulated 
device, intended to be used in ACL and PCL reconstruction surgeries and is 
intended for medical purposes to manipulate tissue, or for use with other 
devices in these surgeries 

 
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• Patient must be 18 years of age or older. 
Exclusion Criteria 
• Any use other than the approved uses indicated in the Instructions for Use 
(IFU). 
IX. 
Study Device Information 
 
EZ Pass Suture Passer: 
The EZ Pass Suture Passers are comprised of a cannulated handle and shaft. A 
nitinol wire or monofilament can be fed through the handle and shaft to facilitate 
suture passing. The thumb wheels on the handle allow for the nitinol wire or 
monofilament to be advanced around the tissue, and then retracted. There are seven 
different shaft tips, which have varying orientations to be used in a variety of procedures. The 
shaft tip orientations include: 90° Up, 45° Up, 45° Dogleg Up, 70° Right, 70° Left, 30° Right, and 
30° Left. To add stability and strength to the EZpass handle, a design change was implemented to 
secure the handle halves together using 8 stainless steel screws instead of the previously used 
ultrasonic welding. See Appendix for specific SKUs associated with the EZPass 
Suture Passers. 
 
 
 
 
 
       Figure 1: EZ Pass Suture Passers 
Precision Flexible Reamer: 
The unique design of the Precision Flexible Instrumentation provides an accurate 

 
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and reproducible system for anatomic ACL reconstruction. The curved guides and 
flexible drills facilitate tunnel placement at the true ligament origin, optimizing the native 
kinematics of the ACL graft. The dual plane geometry of the system offers the additional 
advantages of predictable and consistent tunnel position and length, without requiring 
hyperflexion of the knee during tunnel preparation. 
 
The Precision Instrumentation allows various offset reference options along with 
alternative universal free-hand guides to accommodate surgeon preferences and 
anatomic variations and is compatible with numerous graft fixation options. 
 
 
 
 
    Figure 2: Precision Flexible Reamer 
X. 
Study Procedures 
a) Screening and Informed Consent 
The investigator will screen clinic records to identify all consecutive patients that 
received treatment with the EZ Pass Suture Passer or Precision Flexible Reamer. 
Subjects who meet all of the inclusion criteria and none of the exclusion criteria 
will be invited to participate in the study, unless a waiver of consent is obtained 
from the IRB/EC. If no consent waiver is obtained, all patients must sign a written 
Informed Consent form approved by the IRB/EC. 
b) Subject Identification 
When a subject is enrolled, they will receive a unique case ID allocated by the 
investigator. The number will be allocated according to the chronological order of 
enrollment in the study. Subjects treated with both the EZ Pass Suture Passer 
and the Precision Flexible Reamer will require two different case IDs. The case ID 
must be recorded on all study documentation related to the enrolled patient. The 
investigator is responsible to provide all data as defined by the protocol to Zimmer 
Biomet. 

 
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c) Data Collection 
Data will be recorded in a standardized way either electronically or on paper and 
copies are to be provided to Zimmer Biomet Clinical Affairs. Every effort must be 
made to ensure data submission to the Sponsor is made within 30 days of the 
data collection. The Investigator is responsible for the accuracy, completeness, 
legibility, and timeliness of all documented data for each individual subject. The 
Sponsor will maintain quality control systems, in accordance with the Sponsor’s 
policies and procedures. 
The following information will be collected and documented (if available) for each 
subject treated with the EZ Pass Suture Passer or the Precision Flexible Reamer 
and enrolled into the study: 
Survey: 
o Year of Birth 
o Gender 
o Height 
o Weight 
o Operative Side 
o Year of Surgery 
o Reason for use of the instrumentation 
 
 
o Instrument/Implant details 
o Operative Time (skin to skin) 
o Blood loss 
o Complications/adverse events (relation to either implant or instrumentation 
should be specified) 
 
d) Data Management 
Discrepancy checks will be done based on the data collected. If any discrepancies 
are identified, Zimmer Biomet’s designated monitor will contact the site for 
clarification and correction, as necessary. 
e) Completion of the Study 
This study will be considered fully complete once post-operative data has been 
collected for 51 subjects who received treatment with the EZ Pass Suture Pass 
and 51 subjects who received treatment with the Precision Flexible Reamer. 

 
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XI. 
Reporting 
The management of all study data received by the Sponsor will be the 
responsibility of the Sponsor or its Designee. The use or disclosure of all 
Protected Health Information (PHI) will comply with the Health Insurance 
Portability and Accountability Act (HIPAA) and General Data Protection 
Regulation (GDPR), as applicable. All information will be treated with strict 
adherence to professional standards of confidentiality and will be filed by the 
Sponsor under adequate security and restricted accessibility by clinical personnel. 
All electronic systems used to create, modify, maintain, or transmit study records 
will be validated according to 21 CFR Part 11. Reports and communications 
relating to study subjects will typically identify each subject only by the subject’s 
assigned study subject Case ID number, date of surgery, operative side, and date 
or year of birth.  All personally identifiable information on the source document 
CRFs will be pseudonymized in accordance with regional and/or national data 
privacy protection laws/regulations.  The collection and processing of personal 
data from subjects enrolled in this study will be limited to those data that are 
necessary to investigate the efficacy, safety, quality, and utility of the 
investigational product(s) used in this study. 
Activities Required Prior to Initiation of the Study 
Clinical Trial Agreement (CTA) and Financial Arrangements 
A fully executed (signed by all required parties) CTA must be on file with the Sponsor 
prior to any investigator participating in this study.  This agreement must explain the 
financial arrangement with the investigative site. 
For this study, funding is made available by Zimmer Biomet to support clinical data 
collection, IRB/EC review fees and other expenses associated with the conduct and 
execution of this study protocol. 
Institutional Review Board/Ethics Committee Protocol Approval 
This study protocol must be submitted to and approved by the Investigator’s 
Institutional Review Board (IRB) or Ethics Committee (EC).  A copy of the IRB or EC 
approval letter must be submitted to the Sponsor.  The letter should identify the 
following: 
 
• Protocol name and/or number. 
• Date of IRB or EC meeting (if available). 
• Date of approval. 
• Date of expiration. 

 
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• Signature of IRB or EC. 
ClinicalTrials.gov Registration 
The Sponsor will be responsible for registering this study on www.ClinicalTrials.gov if 
required by local and national regulations. 
Clinical Data Collection/Submission 
Summary of Case Report Form Data Collection 
Study data will be collected on source documents which may include study-specific 
worksheets provided by the Sponsor.  For subjects having bilateral arthroplasties, 
separate case report forms must be completed for each operative side. 
The following source document/CRF completion guidelines should be followed: 
• Complete carefully and accurately. 
• Complete header information consistently across all case report forms for each 
individual study subject (when study-specific CRFs are used). 
• Be sure that data on the source documents match that which is entered through 
the electronic data capture (EDC) system. 
• Use the study subject’s unique Case ID number assigned as instructed.  Do not 
provide information that is not requested on the CRFs. 
• Ensure that all fields are completed.  For fields completed by the subject, efforts 
should be made to obtain any missing responses prior to the subject completing 
their visit. 
Data Submission 
Completed CRFs will be submitted directly to the Sponsor by electronic data capture 
and submission via a method approved by the Sponsor.  Every effort must be made 
to ensure data submission to the Sponsor is made within 30 days of the visit 
completion. 
Quality Assurance of Data 
The Investigator should ensure the accuracy, completeness, legibility, and timeliness 
of the data reported to the Sponsor in the CRFs and in all required reports.  Data 
reported on the CRF, which are derived from source documents, should be 
consistent with the source documents or the discrepancies should be explained.  All 
electronic systems used to create, modify, maintain, or transmit electronic study 
records will be validated.  The Sponsor will maintain quality control systems, in 
accordance with the Sponsor’s policies and procedures. 

 
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Reporting Requirements 
Investigator Reporting Responsibilities 
The Investigator should ensure the accuracy, completeness, legibility, and timeliness 
of data reported to the Sponsor in accordance with this protocol.  The Investigator or 
Designee will provide periodic reports to their IRB or EC as required to maintain IRB 
or EC approval throughout the study, and will provide any required final reporting to 
the IRB or EC upon study completion/termination.  A copy of all IRB or EC re-
approval letters must be submitted to the Sponsor.  If the IRB or EC terminates or 
suspends its approval of the study, the Investigator or Designee will suspend study-
related activities and will promptly notify the Sponsor.  The Investigator should also 
promptly provide written reports to the Sponsor and the IRB or EC regarding any 
changes significantly affecting the conduct of the study, and/or increasing risk to the 
subjects.  
Retention of Records 
Study records must be retained by the Investigator or Designee for a minimum of 15 
years from the Investigator’s study termination date, or per applicable regulatory 
and/or IRB or EC requirements (whichever time period is greater).  Measures shall be 
taken to prevent accidental or premature destruction.   
Study records are defined as the all information in original records, certified copies of 
original records of clinical findings, observations or other activities in a clinical study, 
including source data initially recorded in an electronic format, necessary for the 
reconstruction and evaluation of the clinical study.  This may include but is not limited 
to: hospital records, clinic records, laboratory notes, device accountability records, 
photographs, radiographs, subject casebooks, regulatory records, signed informed 
consents and all other study-related documents. 
Management of Intercurrent Events 
Failure to Obtain Informed Consent 
Study data will not be collected until the Informed Consent has been signed and 
dated by the candidate, unless a waiver for consent has been issued by the IRB/EC.  
If a candidate does not wish to participate (does not sign and date the Informed 
Consent), data for that candidate will not be collected for this study. 
Adverse Events 
See Safety Management – Medical Events/Adverse Events Section of this protocol 
for additional information regarding adverse event classifications.   
Reporting and Documentation of Adverse Events and Adverse Device Effects  

 
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Adverse Events and Adverse Device Effects have to be documented on the Adverse 
Event Report form over the whole time of the investigation including information on 
the date of onset, treatment and resolution, as well as assessment of both the 
seriousness and the relationship to the study device.  Further, the outcome of 
complications has to be documented and any changes in outcome are to be updated 
during the course of the study.  In case of early termination of the study, further 
follow-up of the patient shall proceed according to the hospital’s standard procedure. 
Reporting and Documentation of Serious Adverse Events, Serious Adverse Device 
Effects, and Device Deficiencies 
Serious Adverse Events and Serious Adverse Device Effects have to be 
reported to the Sponsor as soon as possible.  The incidence has to be 
documented on the Adverse Event Report form over the whole time of the 
investigation including information on the date of onset, treatment and resolution, as 
well as assessment of both the seriousness and the relationship to the study device 
based on the evaluation of the investigator.  The outcome of such complications has 
to be documented and any changes in outcome have to be updated during the 
course of the study.  In case of early termination of the study, further follow-up of the 
study subject shall proceed according to the hospital’s standard procedure. 
Device Deficiencies that did not lead to an adverse event but could have led to a 
medical occurrence if suitable actions had not been taken, if intervention had not 
been made or if circumstances had been less fortunate shall be reported to the 
Sponsor as soon as possible, as well. 
The Investigator is responsible for reporting all SAEs, SADEs and Device 
Deficiencies that could have led to a SADE to the Ethics Committee or Institutional 
Review Board if required by national regulations or by the IRB/EC. 
Revision 
In the event that removal of one or more of the study related components is 
necessary, the Investigator will determine the best treatment and/or revision method 
for the subject.  Once the revision surgery has been completed, the Investigator or 
qualified Designee must complete an Adverse Event Report case report form. 
Investigator Withdrawal 
The Investigator can choose to withdraw a subject from the study if it is deemed to be 
in the subject’s best interest or the subject does not consent to continue in the study 
after being informed of changes in the research that might affect them.   
Protocol Deviations 
The Investigator should not deviate from the agreed upon protocol unless it is to 
eliminate hazard to the patient.  However, any deviation from the protocol has to be 
documented along with an explanation for the deviation and reported to the Sponsor.  

 
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Each significant deviation will be reported to the Ethics Committee or Institutional 
Review Board, if applicable, within the appropriate deadlines stipulated by the 
appropriate regulatory authorities.  Significant deviations are defined as those 
impacting or potentially impacting patient safety.  The sponsor shall take appropriate 
corrective and preventative actions to protect the safety of subjects, users, and other 
persons. Investigator disqualification criteria leading to exclusion from the clinical 
study include fraud, misconduct and serial non-compliance. 
Study Termination 
Study subject participation is expected to end upon completion of the Operative 
Survey for each subject.  
If the Sponsor decides to terminate the study early, the Sponsor will inform the 
Investigators of the reason for early study termination.  It is the responsibility of the 
Investigators to inform their IRB or EC as applicable according to local and national 
laws/regulations.   
Modification of the Protocol 
All amendments to this clinical protocol shall be agreed to by the Sponsor and be 
recorded with a justification for the amendment prior to implementation.  Approval of 
the applicable IRB or EC must be obtained prior to implementation, if required 
according to the local and/or national laws/regulations.  
XII. Safety Management – Medical Events/Adverse Events  
Adverse events are required to be reported on the Adverse Event Report case 
report form.  The completed Adverse Event Report case report form must be 
submitted to the Sponsor in a timely manner.  The Investigator or Designee will 
also promptly provide the Sponsor with any additional requested information 
required for the Sponsor to comply with regulatory requirements.  If applicable per 
their reporting requirements, the Investigator or Designee will also report 
applicable adverse event(s) to their IRB or EC. 
The following definitions are from ISO 14155:2020. 
Classification of the Event 
Adverse Event (AE): 
An adverse event is any untoward medical occurrence, unintended disease or 
injury, or untoward clinical signs (including abnormal laboratory findings) in 
subjects, users or other persons, whether or not related to the investigational 
medical device and whether anticipated or unanticipated. 
Note 1:  This definition includes events related to the investigational medical 
device or the comparator. 

 
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Note 2:  This definition includes events related to the procedures involved. 
Note 3:  For users or other persons, this definition is restricted to events related to 
investigational medical devices or comparators.  
Serious Adverse Event (SAE): 
A Serious Adverse Event is an adverse event that led to any of the following: 
• death, 
• serious deterioration in the health of the subject, users or other persons as 
defined by one or more of the following: 
• a life-threatening illness or injury, or 
• a permanent impairment of a body structure or a body function including 
chronic diseases, or 
o in-patient or prolonged hospitalization, or 
o medical or surgical intervention to prevent life-threatening illness or 
injury or permanent impairment to a body structure or a body 
function, 
• led to fetal distress, fetal death or a congenital abnormality or birth defect 
including physical or mental impairment. 
Note:  Planned hospitalization for a pre-existing condition, or a procedure 
required by the protocol, without serious deterioration in health, is not considered 
a serious adverse event. 
Adverse Device Effect (ADE): 
An Adverse Device Effect is an adverse event related to the use of an 
investigational medical device. 
Note 1:  This definition includes adverse events resulting from insufficient or 
inadequate instructions for use, deployment implantation, installation, or 
operation, or any malfunction of the medical device. 
Note 2:  This definition includes any event resulting from use error or from 
intentional misuse of the medical device. 
Serious Adverse Device Effect (SADE): 
A Serious Adverse Device Effect is an adverse device effect that has resulted in 
any of the consequences characteristic of a serious adverse event. 
Unanticipated Serious Adverse Device Effect (USADE) 
An unanticipated adverse device effect is a serious adverse device effect which 
by its nature, incidence, severity or outcome has not been identified in the current 
version of the risk analysis report. 

 
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Note 1: Anticipated serious adverse device effect (ASADE) is an effect which by 
nature, incidence, severity or outcome has been identified in the risk analysis 
report. 
Device Deficiency (DD): 
A Device Deficiency is defined as an inadequacy of a medical device with respect 
to its identity, quality, durability, reliability, usability, safety or performance.  
Note:  Device Deficiencies include malfunctions, use errors, and .inadequacy in 
the information supplied by the manufacturer including labeling.  
It is important to document in the study also all device deficiencies that could have 
led to a medical occurrence but did not lead to an adverse event. 
Serious Health Threat 
Signal from any adverse event or device deficiency that indicates an imminent risk 
of death or a serious deterioration in the health of subjects, users or other 
persons, and that requires prompt remedial action for other subjects, users or 
other persons. 
Note 1: This would include events that are of significant and unexpected nature 
such that they become alarming as a potential serious health hazard or possibly 
of multiple deaths occurring at short intervals. 
Intensity of Symptoms 
Mild: 
The subject is aware of the sign or symptom, but finds it easily tolerated.  The 
event is of little concern to the subject and/or little clinical significance.  The event 
is not expected to have any effect on the subject’s overall health or well-being. 
Moderate: 
The subject has discomfort enough to cause interference with or a change in 
usual activities.  The event is of some concern to the subject’s health or well-being 
and may require medical intervention and/or close follow-up. 
Severe: 
The event interferes considerable with the subject’s usual activities.  The event is 
of definite concern to the subject and/or poses substantial risk to the subject’s 
health or well-being.  The event is likely to require medical intervention and/or 
close follow-up and may be incapacitating or life threatening.  Hospitalization and 
treatment may be required. 
Note:  The term “severe” refers to the intensity of the event and can be used with 
any event, without regard to whether or not it meets the criteria for being classified 
as “serious” or “unanticipated”.  For example, a subject can have a severe 
headache, but it is not a serious event.  

 
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Outcome Definitions 
The outcome is in relationship to the Adverse Event, not the treatment rendered 
for the event (if any). 
Resolved: 
The adverse event has been resolved and/or no further treatment is required to 
treat the reported condition or illness.   
Tolerated: 
The adverse event will most likely never be resolved.  The subject “tolerates” the 
illness or condition as a matter of life. 
Pending: 
Treatment or diagnostic studies were prescribed for the adverse event and the 
outcome of the adverse event is not yet known. 
Reoperation: 
The adverse event resulted in reoperation of the study joint, but the reoperation 
did not include removal of a study device. 
Death: 
The outcome indicates the subject died as a direct result of the reported adverse 
event.  
Review of Reported Events 
The Sponsor will review the investigator’s assessment of all reported events 
submitted to determine and document in writing their seriousness and relationship 
to the study device and related procedures required by this protocol.  In case of 
disagreement, the sponsor will consult the investigator for clarification and 
correction if required.  If the disagreement cannot be resolved, the sponsor shall 
communicate both opinions to the Post Market Surveillance team for further 
investigation and required reporting if applicable . 
XIII. Monitoring 
Prior to initiating the clinical study, the Sponsor may conduct a site qualification 
visit to ensure the Investigator(s) and study staff understands the study protocol 
and requirements and have adequate time and resources to implement and 
conduct the study.  Prior to study initiation, the Investigator must have a fully 
executed CTA and IRB or EC approval of the study protocol and the study 
Informed Consent.  
During the course of the study, the Sponsor will conduct periodic central 
monitoring and maintain contact with the study staff to monitor compliance and 
evidence of adverse events, in accordance with the Sponsor’s policies and 

 
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procedures.  The Sponsor will address any identified non-compliance with the 
executed CTA, study protocol, and applicable regulatory requirements. 
If onsite monitoring visit(s) are deemed appropriate by the Sponsor, the 
Investigator will permit representatives of the Sponsor’s monitoring team to have 
direct access to inspect all source data/documents, study documents/binders, 
study subject case report forms, corresponding sections of study subject 
medical/hospital records, and any other documents relevant to the study.   
XIV. Risk Analysis 
This post-market clinical study is classified as minimal risk, and there are no 
additional or anticipated risks specific to study participation other than the 
potential loss of confidentiality. There are no experimental procedures in this 
study, and participation in this study is not anticipated to affect the medical 
treatment of enrolled subjects.  
When used in accordance with product labeling, the risks associated with the use 
of the EZ Pass Suture Passer and the Precision Flexible Reamer are like that of 
any other suture assistance instrumentation. These risks are either general 
surgical or anesthesia risks or risks associated with the subject procedure/study 
device. Unanticipated adverse events can occur.  
XV. Statistical Methods 
Data collected in the study will be summarized descriptively. Descriptive 
summaries will form the basis of study reports and will generate an overall 
summary of the clinical evaluation of the EZPass Suture Passer and Precision 
Flexible Reamer instrumentation. 
Continuous data (e.g. age) will be summarized through means, medians, standard 
deviation, minimum, maximum and 95% confidence intervals (CIs) over time 
periods of interest. Categorical data (e.g. gender) will be summarized using 
counts, percentages and 95% confidence limits over time periods of interest. 
Summaries of complications data will be presented as frequencies and 
percentages. Subgroup summaries will be generated as needed either by strata 
within the study population (e.g. male vs. female) or by different cut-points (e.g. 
body mass index (BMI) ranges). Patient confidentiality will be protected at all 
times, and patient identifiers will not be included in data summaries 
 

 
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XVI. Quality Control & Quality Assurance 
The study is conducted in accordance with the Declaration of Helsinki and the ISO 
14155:2020.  
The Investigator will be required to permit representative(s) of the Sponsor’s 
monitoring team to inspect all Case Report Forms and corresponding sections of 
the study patients office records and/or hospital original medical records.  These 
audits will be done for quality assurance purposes, i.e. verifying adherence to the 
Clinical Investigation Plan and the completeness and accuracy of the data being 
entered on the Case Report Forms. 
The Clinical Investigation Plan will be provided to all participating study centers.  
The Investigators will be fully trained in the proper reporting and submission of 
trial data prior to patient enrolment.  Completed Case Report Forms will be 
reviewed before entering the data into a central database by the Sponsor. 
The Clinical Study Manager is responsible for generating data queries for missing 
or unclear data if needed.  It is the responsibility of the Clinical Study Manager to 
ensure data quality. 
There are regular meetings between the Investigators and Zimmer Biomet Clinical 
Affairs staff.  Written correspondence to all sites is used to inform the 
Investigators of routine study details and to update them on study status. 
XVII. Suspension or Premature Termination of the Clinical 
Investigation 
The study Sponsor retains the ability to suspend or terminate this study before 
completion. If the study Sponsor decides to do so, the Sponsor will inform the 
Investigator(s) of the reason for early study termination. It is the responsibility of 
the Investigator(s) to inform their IRB/EC, as applicable, according to local and 
national laws/regulations. 
XVIII. Amendments to the Clinical Investigation Plan 
All amendments to this clinical protocol shall be agreed upon by the Sponsor and 
Investigator(s) and be recorded with a justification for the amendment.  Approval 
of the IRB/EC that reviewed the original protocol must be obtained if required 
according to the corresponding regulations.  In the case of an amendment to the 
protocol, the revision history will be documented in the Document History Section 
below. 
XIX. Publication Policy 
Both the Clinical Investigator and the Sponsor have the right to publish or allow 
the results of the clinical trial to be published.  The Clinical Investigator recognizes 

 
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that the Sponsor has a special interest in the results of the clinical study and will 
submit manuscripts to the Sponsor prior to publication.  If the Sponsor desires 
changes to be made, these are communicated to the Clinical Investigator within 
30 days of submission.  Pooled data may be used for training and meetings. 
XX. Document History 
 
 
Revision 
Number 
Date 
Description of Change 
Person in Charge 
of Change 
v4.0 
15 Sep 2019 
Initial Release 
Kate Conrad 
v4.1 
27 Apr 2021 
Updated to latest version of GBLF12202 
Added elements to comply with ISO 
14155:2020: 
Cover page – Added sponsor name and 
address 
Added Section I Contact List & 
Section II Abbreviations 
Added missing elements in Section III 
Study Synopsis 
Clarified Study Objectives in Section VI 
Added clarification to study design in 
Section VII Study Design 
Clarified study activities that occur 
throughout the study in Section X Study 
Procedures 
Added description of study completion in 
Section X, part e) 
Clarified reporting responsibilities of 
sponsor and investigator in Section XI 
Reporting 
Updated definitions of Adverse Events to 
match definitions in ISO 14155:2020 in 
Section XII Safety Management – Medical 
Events/Adverse Events 
Added Section XIII Monitoring and Section 
XIV Risk Analysis to comply with ISO 
14155:2020 standard 
Clarified quality requirements in Section 
XVI Quality Control & Quality Assurance 
Added Section XVII Suspension or 
Premature Termination of the Clinical 
Investigation, Section XVIII Amendments 
Branden Kemp 

 
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to the Clinical Investigation Plan, Section 
XIX Publication Policy, and Section XX 
Document History to comply with ISO 
14155:2020 standards. 
XXI. References 
 
1. Clinical Investigation of medical devices for human subjects - Good Clinical 
practice. ISO 14155:2020, 2020. 
 
2. WORLD MEDICAL ASSOCIATION DECLARATION OF HELSINKI, Ethical 
Principles for Medical Research Involving Human Subjects. 59th WMA 
General Assembly, Seoul, 2008. 
 
 
 

 
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Appendix A: SKUs and Descriptions 
EZ Pass Suture Passer: 
- 
904050: EZ Pass 90 Deg Up 
- 
904051: EZ Pass 45 Deg Up 
- 
904052: EZ Pass 45 Deg Dog Leg Up 
- 
904053: EZ Pass 70 Deg Right 
- 
904054: EZ Pass 70 Deg Left 
- 
904055: EZ Pass 30 Deg Right 
- 
904056: EZ Pass 30 Deg Left 
- 
110007379: Suture Shuttle Monofilament 
- 
110007380: Suture Shuttle Kite 
- 
110008588: EZ Pass 70 Deg Left 10 Pack 
- 
110008589: EZ Pass 45 Deg Dog Leg Up 10 Pack 
- 
110008590: EZ Pass 45 Deg Up 10 Pack 
- 
110008591: EZ Pass 30 Deg Right 10 Pack 
- 
110008592: EZ Pass 30 Deg Left 10 Pack 
- 
110008593: EZ Pass 90 Deg Up 10 Pack 
- 
110008594: EZ Pass 70 Deg Right 10 Pack 
 
Precision Flexible Reamer:  
- 
110009769: Precision MPF Nitinol SMA Guide Wire 
- 
110008343: Precision SMA Guide Wire 5 Pack 
- 
110004180: Precision Flexible Reamer 4.5mm Disposable 
- 
110004185: Precision Flexible Reamer 7.0mm Disposable 
- 
110004186: Precision Flexible Reamer 8.0mm Disposable 
- 
110004187: Precision Flexible Reamer 9.0mm Disposable 
- 
110004188: Precision Flexible Reamer 10.0mm Disposable 
- 
110004189: Precision Flexible Reamer 11.0mm Disposable 
- 
110004190: Precision Flexible Reamer 12.0mm Disposable 
- 
110010577: Precision Flexible Reamer 7.5mm Disposable 

 
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- 
110010578: Precision Flexible Reamer 8.5mm Disposable 
- 
110010579: Precision Flexible Reamer 9.5mm Disposable 
- 
110010580: Precision Flexible Reamer 10.5mm Disposable  
- 
110010581: Precision Flexible Reamer 11.5mm Disposable