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

Catalog Number	00590103300
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).G2: foreign: canada.Customer has indicated that the product is in process of being returned to zimmer biomet for evaluation.The investigation is in progress.Upon completion of the investigation, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that during a total knee arthroplasty, the impactor tip fractured during impaction of the tibial tray.There was no patient impact and no adverse events have been reported as a result of the malfunction.Backup instrumentation was used to complete the procedure without further incident.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections have been updated: b4; b5; d9; g3; h2; h3; h4; h6; h11.Visual examination of the returned product identified signs of use (dings on the tip and scratches).The device is fractured into two pieces.All pieces were returned.Dimensional analysis of the product determined that the product, where measured, was conforming to its print specifications.Reported event was confirmed by complaint sample evaluation.Device history record was reviewed and no discrepancies related to the reported event were found.Investigation results concluded that the reported event is attributed to wear and tear of the device from repeated use over time.The device has a potential field age of eight (8) years and exhibits signs of repeated use.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: NEXGEN TIBIAL IMPACTOR BLOCK
• 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: 23423975
• Report Number: 0001822565-2025-03906
• Device Sequence Number: 15836840
• Product Code: LXH
• UDI-Device Identifier: 00889024201675
• UDI-Public: (01)00889024201675(10)63571634
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2026

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: 00590103300
• Device Lot Number: 63571634
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2025
• Supplement Date Received by Manufacturer: 03/19/2026
• Initial Report FDA Received Date: 10/30/2025
• Supplement Report FDA Received Date: 03/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/08/2017
• 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