MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ZIPLOOP BUTTON 10MM; IMPLANT - SPORTS MEDICINE

Catalog Number 110010873

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Information (3190)

Event Date 02/03/2015

Event Type  malfunction  

Manufacturer Narrative

The product was not available for return.Review of device history records found units released for distribution with no deviation or anomaly.Review of complaint history found three other complaint for this lot ((b)(4)).A trend was identified and is addressed in ca-01788 and hhe 15-03.Manufacturing deficiency.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.Completion of the investigation relayed to biomet (b)(4) via etq.This report is being submitted late as it has been identified in remediation.

Event Description

It was reported that patient underwent a femoral fixation procedure on (b)(6) 2015.During the procedure, it was noted that the inner packaging of the toggleloc ziploop was not sealed.Another toggleloc ziploop was utilized to complete the procedure.

• Brand Name: ZIPLOOP BUTTON 10MM
• Type of Device: IMPLANT - SPORTS MEDICINE
• 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: 6950885
• MDR Text Key: 90248589
• Report Number: 0001825034-2017-08673
• Device Sequence Number: 1
• Product Code: MAI
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: PNOT LISTED
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 10/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 110010873
• Device Lot Number: 209340
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/04/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/23/2014
• 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