MDR EZ Pass and Precision Flexible Reamer

Study Overview
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Brief Summary
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The objective of this study is to confirm the safety and performance on the EZPass Suture Passer Instrumentation and the Precision Flexible Reamer Instrumentation. Ultimately, clinical performance will be assessed through survey questions that evaluate the safety and performance of these instruments.

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

Official Title
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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
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Rotator Cuff Tear, Anterior Cruciate Ligament Injury

Intervention / Treatment
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* Procedure: EZ Pass Suture Passer


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| EZ Pass Suture Passer<br>Patients who have surgery using the EZ Pass Suture Passer Instrument either in rotator cuff or soft tissue repair | Procedure: EZ Pass Suture Passer<br>* Instruments used to help with rotator cuff or ACL repair<br>|
| Precision Flexible Reamer<br>Patients who have surgery using the Precision Flexible Reamer Instrument in ACL repair | Procedure: EZ Pass Suture Passer<br>* Instruments used to help with rotator cuff or ACL repair<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance of Instruments based on Patient Questionnaire (EZ Pass Suture Passer and Precision Flexible Reamer) | Questionnaire will be completed to assess if the Instrument Perform as Expected. Questions to include are: Which Instrument was used? EZ Pass Suture Passer or Precision Flexible Reamer Which Procedure was performed? Rotator Cuff or ACL OR Time (Skin to Skin) in Minutes Did the instrument perform as expected? Yes or No Did the Instrument break? Yes or No Blood Loss during Surgery? Minimal, Moderate or Severe Intraoperative Complications Yes or No | Intraoperative | 
| Absence of Instrument Related Serious Adverse Events | This outcome will measure the frequency of instrument related serious adverse events | Intraoperative |