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

Catalog Number	00595109000
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).G2: foreign: germany.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.H3 other text : see h10 narrative.
Event or Problem Description
It was reported that during an initial total knee procedure, the tibial broach instrument broke.There was no patient impact and no adverse events have been reported as a result of the malfunction.Due diligence is in progress for this event; to date no further information has been reported.
Additional Manufacturer Narrative
H6: proposed component code: mechanical (g04) - impactor visual examination of the returned product identified signs of repeated use (tool marks) and the impact area on the instrument has fractured from the body of the device.The device was submitted for further analysis.Analysis determined the weld fracture surfaces exhibited river lines and tensile overload artifacts suggesting that the device possibly fractured due to tensile overload mode of failure.Device history record was reviewed and no discrepancies related to the reported event were found.Root cause was unable to be determined.Complaint sample was evaluated and the reported event was confirmed.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 or Problem Description
No further event information at time of this report.

• Brand Name: TIBIAL BROACH IMPACTOR
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 18150471
• Report Number: 0001822565-2023-03229
• Device Sequence Number: 12417730
• Product Code: HWA
• UDI-Device Identifier: 00889024207707
• UDI-Public: (01)00889024207707(10)63560673
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2024

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 Catalogue Number: 00595109000
• Device Lot Number: 63560673
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2023
• Supplement Date Received by Manufacturer: 04/03/2024
• Initial Report FDA Received Date: 11/16/2023
• Supplement Report FDA Received Date: 04/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/13/2016
• 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: Prefer Not To Disclose