MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UJOINT SCRW DRVR BIT 3.5 HEX PROSTHESIS, HIP

Model Number N/A

Device Problems Fracture (1260); Naturally Worn (2988)

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

Event Date 02/19/2020

Event Type  Malfunction  

Manufacturer Narrative

(b)(4). D11: (b)(6). Product has been received by zimmer biomet and the investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported the patient underwent an initial total hip arthroplasty. During the procedure, the articulating screwdriver tip sheared off while removing the screw covers. They were able to retrieve all the metal. The apical hole plug stripped. The surgeon was unable to remove the stripped apical hole plug, and were unable to use the dual mobility poly as a result. They attempted to remove the plug with the flexible screwdriver, straight driver, additional articulating driver, and a screw removal tray. There was no patient harm or delay in surgery. Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: UJOINT SCRW DRVR BIT 3.5 HEX
• Type of Device: PROSTHESIS, HIP
• 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: 9841435
• MDR Text Key: 188265669
• Report Number: 0001825034-2020-01135
• Device Sequence Number: 1
• Product Code: HTW
• Combination Product (Y/N): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: DISTRIBUTOR,HEALTH PROFESSION

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 04/07/2020

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 03/17/2020
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device MODEL Number: N/A
• Device Catalogue Number: 31-424202
• Device LOT Number: ZB160301
• Was Device Available For Evaluation?: Device Returned To Manufacturer
• Date Returned to Manufacturer: 03/11/2020
• Is The Reporter A Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 04/02/2020
• Was Device Evaluated By Manufacturer?: No
• Date Device Manufactured: 04/01/2016
• Is The Device Single Use?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: NI