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

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Patient Involvement (2645)

Event Date 12/11/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 that while auditing instruments, the device was located with a chip in the top of it.This was not used in a case so it did not affect any patient and/or case.

Manufacturer Narrative

Visual examination of the returned product identified signs of repeated use.The tip of the instrument was fractured.The potential field age of the instrument is about 21 years.The dhr was reviewed and no discrepancies relevant to the reported event were found.The root cause of the reported issue is attributed to repeated use of the instrument for more than 21 years.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: STEMMED TIBIAL BROACH IMPACTOR
• Type of Device: INSTRUMENT, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11081851
• MDR Text Key: 224131957
• Report Number: 0001822565-2020-04230
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 02/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 00597701100
• Device Lot Number: 59660300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/11/2020
• Initial Date FDA Received: 12/28/2020
• Supplement Dates Manufacturer Received: 02/26/2021
• Supplement Dates FDA Received: 02/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1