MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TUNNELOC TIBIAL FIXATION 9MM; FASTENER, FIXATION

Model Number N/A

Device Problems Misassembled (1398); Incomplete or Missing Packaging (2312)

Patient Problem No Patient Involvement (2645)

Event Date 05/20/2014

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Complaint sample was evaluated and the reported event was confirmed.Engineer's evaluation relayed "pmc identified the issues and took corrective action in developing new inspection procedures." dhr was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required as no were trends identified.Investigation results concluded that the reported event was due to supplier control.This report is being submitted late as it has been identified in remediation.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.This report is being submitted late as it has been identified in remediation.

Event Description

It was reported that the implant was not found in the packaging, and the peek anchor was not loaded on the tensioning device.

• Brand Name: TUNNELOC TIBIAL FIXATION 9MM
• Type of Device: FASTENER, FIXATION
• 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: 6942433
• MDR Text Key: 90301725
• Report Number: 0001825034-2017-08478
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK103145
• 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
• Report Date: 10/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Model Number: N/A
• Device Catalogue Number: 906513
• Device Lot Number: 356345
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/20/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/16/2013
• 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