MDR EZ Pass and Precision Flexible Reamer

June 27, 2025 updated by: Zimmer Biomet

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

The objective of this study is to confirm the safety and performance on the EZPass Suture Passer Instrumentation and the Precision Flexible Reamer Instrumentation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The primary objective of the study is to assess performance, clinical benefits and safety of the EZPass Suture Passer and the Precision Flexible Reamer Instrumentation.

Performance and clinical benefits will be assessed through an operative survey conducted immediately following intraoperative surgery to determine if the device performed as expected.

Safety will be assessed by recording and analyzing the incidence and frequency of complications, adverse events, and intra-operative revisions.

Study Type

Observational

Enrollment (Actual)

73

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Charlotte, North Carolina, United States, 28277
        • OrthoCarolina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population should be a consecutive series of subjects where the EZPass Suture Passer or Precision Flexible Reamer instrumentation will be used.

Description

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.

Exclusion Criteria

  • EZ Pass Suture Passer:

    - Any use other than the approved uses indicated in the Instructions for Use (IFU).

  • Precision Flexible Reamer:

    • Any use other than the approved uses indicated in the Instructions for Use (IFU).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
EZ Pass Suture Passer
Patients who have surgery using the EZ Pass Suture Passer Instrument either in rotator cuff or soft tissue repair
Procedure: EZ Pass Suture Passer
Instruments used to help with rotator cuff or ACL repair
Precision Flexible Reamer
Patients who have surgery using the Precision Flexible Reamer Instrument in ACL repair
Procedure: EZ Pass Suture Passer
Instruments used to help with rotator cuff or ACL repair

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Absence of Instrument Related Serious Adverse Events
Time Frame: Intraoperative
This outcome will measure the frequency of instrument related serious adverse events
Intraoperative
Performance of Instruments (EZ Pass Suture Passer and Precision Flexible Reamer)
Time Frame: Intraoperative
Questionnaire was completed to assess if the Instrument Performed as Expected. Surgeon provided yes/no answers on their opinion if the instrument performed as expected during the procedure.
Intraoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zimmer Biomet

Investigators

  • Study Director: Erin Osborn, Zimmer Biomet

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 8, 2019

Primary Completion (Actual)

December 31, 2023

Study Completion (Actual)

April 8, 2024

Study Registration Dates

First Submitted

April 11, 2019

First Submitted That Met QC Criteria

April 11, 2019

First Posted (Actual)

April 16, 2019

Study Record Updates

Last Update Posted (Estimated)

July 1, 2025

Last Update Submitted That Met QC Criteria

June 27, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MDRG2017-89MS-32SM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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