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

Catalog Number	00-5901-033-00
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tibial impactor fractured.There was no patient impact as a result of the malfunction.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional 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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d2, g1, g3, g6, h1, h2, h3, h6.The cmp was confirmed.Visual inspection of returned device exhibits signs of repeated use (nicked and gouged) and has fractured into 2 pieces (one of the tabs has fractured off).All pieces returned.Dimensional analysis of the product determined that the product, where measured, was conforming to print specifications.The features of the fracture surface visually align with summary of failure analysis of knee impactor fractures in which an overload fracture failure mode was identified.Review of the device history record identified no deviations or anomalies during manufacturing.Reported event is not related to a combination of products; therefore, a compatibility review is not applicable.Review of complaint history identified additional similar complaints for the reported item and one additional complaint for the reported part and lot combination.Complaints are monitored through monthly complaint review in order to identify potential adverse trends.Medical records were not provided.The lot has been in the field for approximately 6+ years.It is unknown for how many times the device is being used.The root cause can be contributed to normal wear and tear of device.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 or Problem Description
No further information is available at the time of this report.

• Brand Name: TIBIAL IMPACTOR BLOCK
• Common Device Name: KNEE 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: 23728526
• Report Number: 0001822565-2025-04396
• Device Sequence Number: 16006498
• Product Code: LXH
• UDI-Device Identifier: 00889024201675
• UDI-Public: (01)00889024201675(11)190507(10)64272757
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2026

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: 00-5901-033-00
• Device Lot Number: 64272757
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2025
• 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: 11/21/2025
• Supplement Date Received by Manufacturer: 03/19/2026
• Initial Report FDA Received Date: 12/05/2025
• Supplement Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/07/2019
• 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