MAUDE Adverse Event Report: ZIMMER BIOMET, INC. EZ PASS 70 DEGREE RIGHT; SPORTS MEDICINE INSTRUMENTATION

Catalog Number 904053

Device Problem Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/06/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source: (b)(6).Complaint sample was evaluated and the reported event was confirmed.Visual examination of the returned product identified one part with the nitinol kite closed.Second part was returned where one has a broken kite and bio-material blocking the kite.The other one has bio-material blocking the kite from deploying.The ez pass handles moves the nitinol as intended except for the one that is broken.The one with the bio-material moves the nitinol wire but does not deploy it out of the tip.Review of the device history records identified no deviations or anomalies during manufacturing.The root cause of the reported issue is attributed to off-label use as this device was being used in an open bankart procedure.This instrument is intended to be used arthroscopically.It is unknown which instrument was broken.A summary of the investigation has been sent to the complainant.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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2019 - 03310.

Event Description

It was reported that the suture passer instruments did not open up the loop for catching the suture during the open bankart procedure.First time the loop open properly, but with the second suture the loop stayed close.The surgeon tried two (2) extra instruments with the same result.Upon evaluation of the device, fracture was noted on the kite wire.No additional patient consequences are known.

• Brand Name: EZ PASS 70 DEGREE RIGHT
• Type of Device: SPORTS MEDICINE INSTRUMENTATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 8845668
• MDR Text Key: 153120688
• Report Number: 0001825034-2019-03309
• Device Sequence Number: 1
• Product Code: HWQ
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/17/2021
• Device Catalogue Number: 904053
• Device Lot Number: 438150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/24/2019
• Initial Date FDA Received: 07/31/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/17/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1