MDR EZ Pass and Precision Flexible Reamer

Zimmer Biomet

Status

Completed

Conditions

Rotator Cuff Tear

Anterior Cruciate Ligament Injury

Treatments

Procedure: EZ Pass Suture Passer

Study type

Observational

Funder types

Industry

Identifiers

NCT03914703

MDRG2017-89MS-32SM

Details and patient eligibility

About

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

Full 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.

Enrollment

73 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and 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.

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).