MAUDE Adverse Event Report: ZIMMER BIOMET, INC. DRILL 2.0 MM DIAMETER INSTRUMENT, EXTREMITIES

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Information (3190)

Event Date 12/24/2019

Event Type  Malfunction  

Manufacturer Narrative

(b)(4). Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product location is unknown. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. 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.

Event Description

It was reported in a filed maude report that 2 months ago, a physician was performing a left ulnar collateral ligament repair. During the case, a drill bit broke off while he was using it. An x-ray was performed in the operating room to confirm that all the pieces were recovered and not retained in the patient.

• Brand Name: DRILL 2.0 MM DIAMETER
• Type of Device: INSTRUMENT, EXTREMITIES
• 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: 9732279
• MDR Text Key: 183908255
• Report Number: 0001822565-2020-00660
• Device Sequence Number: 1
• Product Code: HTW
• Combination Product (Y/N): N
• Reporter Country Code: US
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: OTHER

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 05/21/2020

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 02/20/2020
• 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: 00231802000
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 05/20/2020
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Is The Device Single Use?: No
• Is this a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage

• Removal/Correction Number: NI