MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPR RVS BSPLT RMR 25MM SHORT; EXTREMITIES, INSTRUMENT

Model Number 110029136

Device Problem Naturally Worn (2988)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/17/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source: foreign: south africa.Visual examination of the provided photos identified the reamer with worn/rolled edges.Part and lot number could not be visualized.No other conclusions could be made due to the quality of the photos.Device history record 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 will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It was reported that the instrument was found to be worn.No adverse events have been reported as a result of the malfunction.Attempts have been made and additional information on the reported event is unavailable.

• Brand Name: COMPR RVS BSPLT RMR 25MM SHORT
• Type of Device: EXTREMITIES, INSTRUMENT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 14955972
• MDR Text Key: 300549830
• Report Number: 0001825034-2022-01534
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 00880304731523
• UDI-Public: (01)00880304731523(11)191015(10)379940
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K193373
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 110029136
• Device Catalogue Number: 110029136
• Device Lot Number: 379940
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/15/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose