N/A
Completed N=73
MDR EZ Pass and Precision Flexible Reamer
Source: ClinicalTrials.gov NCT03914703 ↗Enrolled (actual)
73
Serious AEs
0.0%
Results posted
Jul 2025
Primary outcomePrimary: Performance of Instruments (EZ Pass Suture Passer and Precision Flexible Reamer) — 49; 22; 2; 0 Participants
Summary
The objective of this study is to confirm the safety and performance on the EZPass Suture Passer Instrumentation and the Precision Flexible Reamer Instrumentation.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Performance of Instruments (EZ Pass Suture Passer and Precision Flexible Reamer) |
49; 22; 2; 0 | — |
| PRIMARY Absence of Instrument Related Serious Adverse Events |
51; 22; 0; 0 | — |
Eligibility 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.
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).
Data sourced from ClinicalTrials.gov (NCT03914703). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.