MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BONE SCREW DRILL 3.2 MM DIAMETER INSTRUMENT, SURGICAL

Model Number N/A

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/07/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4). Customer has indicated that the product is in process of being returned to zimmer biomet for investigation. Once the investigation has been completed, a follow-up mdr will be submitted. Report source: event occurred in (b)(6).

Event Description

It was reported that during an initial tka, the surgeon was drilling through the cutting guide and the drill fractured inside of the patient's bone. The surgeon did notice this until the fragment was seen on x-ray postoperatively, and decided not to remain it. Attempts have been made and no further information has been provided.

• Brand Name: BONE SCREW DRILL 3.2 MM DIAMETER
• Type of Device: INSTRUMENT, SURGICAL
• 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: 9653531
• MDR Text Key: 177373618
• Report Number: 0001822565-2020-00416
• Device Sequence Number: 1
• Product Code: HTW
• Combination Product (Y/N): N
• Reporter Country Code: JA
• 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

• Type of Report: Initial,Followup,Followup
• Report Date: 03/19/2020

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 01/31/2020
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device MODEL Number: N/A
• Device Catalogue Number: 00512008500
• Device LOT Number: 55427000
• Was Device Available For Evaluation?: Device Returned To Manufacturer
• Date Returned to Manufacturer: 02/03/2020
• Is The Reporter A Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 03/18/2020
• Was Device Evaluated By Manufacturer?: Yes
• Date Device Manufactured: 11/05/2002
• Is The Device Single Use?: No
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown

Patient TREATMENT DATA

Date Received: 01/31/2020 Patient Sequence Number: 1