MAUDE Adverse Event Report: ZIMMER BIOMET, INC. EXACT OFFSET BROACH HANDLE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	31-555501
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the broach handle instrument would not properly hold the rasp instrument.Upon evaluation of the instrument, the handle was found to be fractured.There was no patient involvement and no adverse events have been reported as a result of this malfunction.It was reported that no further information is available.
Additional Manufacturer Narrative
(b)(4).Report source foreign: germany.Visual examination of the returned product identified the pin cap of the distal most pin to have fractured off.The weld holding the cap to the pin has failed.Discoloration spots are present on the shaft.The impact marks are present on the strike plate and on the shaft near the etching.Device history record was reviewed and no discrepancies related to the reported event were found.Root cause was unable to 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.

• Brand Name: EXACT OFFSET BROACH HANDLE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL 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: 16521122
• Report Number: 0001825034-2023-00495
• Device Sequence Number: 2316182
• Product Code: LXH
• UDI-Device Identifier: 00880304432260
• UDI-Public: (01)00880304432260(11)200210(10)651390
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/08/2023

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
• Operator of Device: Health Professional
• Device Model Number: 31-555501
• Device Catalogue Number: 31-555501
• Device Lot Number: 651390
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2023
• Initial Report FDA Received Date: 03/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/10/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown