MAUDE Adverse Event Report: BIOMET SPORTS MEDICINE EZ PASS 70 DEGREE RIGHT; PASSER

Model Number N/A

Device Problems Positioning Failure (1158); Mechanical Jam (2983)

Patient Problem Tissue Damage (2104)

Event Date 10/03/2016

Event Type  Injury  

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.

Event Description

It is reported that during a labral tissue repair procedure, while attempting to pass the suture through the tissue, the nitinol wire jammed in the device and would not deploy.The surgeon removed the device, and completed the procedure with another device.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: device returned to manufacturer on oct 10, 2016.(b)(4).Complaint sample was evaluated and the reported event was confirmed.The failure mode was identified as functional-jammed as components were stuck.Dhr was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required as no trends were identified.Root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: EZ PASS 70 DEGREE RIGHT
• Type of Device: PASSER
• Manufacturer (Section D): BIOMET SPORTS MEDICINE; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6137116
• MDR Text Key: 61186687
• Report Number: 0001825034-2016-04934
• Device Sequence Number: 1
• Product Code: HWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 09/30/2019
• Device Model Number: N/A
• Device Catalogue Number: 904053
• Device Lot Number: 656190
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/20/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 22 YR