MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TIBIAL BROACH IMPACTOR; INSTRUMENT

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/05/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source: foreign (b)(6).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.

Event Description

It was reported that during a total knee arthroplasty the tibial broach handle fractured during the procedure.No pieces fell into the patient and the procedure was completed without delay.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

(b)(4).The complaint is confirmed.Visual examination of the provided pictures identified the head of the instrument was fractured.The picture shows signs of use.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Medical records were not provided.A definitive root cause cannot be determined.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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; g3; g4; g6; h1; h2; h3; h6 complaint sample was evaluated and the reported event was confirmed.Visual examination of the returned product identified signs of repeated use (impaction marks, gouges, and nicks).The weld which connects the rod head with the rod shaft was fractured.The potential field age of this instrument is 4 years and 1 month.Device history record (dhr) was reviewed and no discrepancies were found.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No further event information available at the time of this report.

• Brand Name: TIBIAL BROACH IMPACTOR
• Type of Device: INSTRUMENT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11156753
• MDR Text Key: 226338327
• Report Number: 0001822565-2021-00100
• Device Sequence Number: 1
• Product Code: HWA
• UDI-Device Identifier: 00889024207707
• UDI-Public: (01)00889024207707(10)63561564
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 05/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2021
• 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: 00595109000
• Device Lot Number: 63561564
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1