MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD FEMORAL SLAP HAMMER; KNEE INSTRUMENT

Catalog Number	32-422365
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).D4 - primary device identification (udi) number is not applicable as the lot number of the device is unknown.G2 ¿ foreign ¿ canada.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported that while using a slap hammer during the surgery, the surgeon noticed it was broken.The spring inside no longer worked.He still used it for the case.There was no impact to the patient, no foreign body retained.No additional information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d4, d9, g3, g6, h2, h3, h4, h11.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 available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and corrected information.The following sections were updated: b4, b5, g3, g6, h2, h3, h6, h11.The following section was corrected: h4.Complaint can be confirmed through the returned product analysis.Visual evaluation showed that the returned part exhibits signs of use (dings, scratches) and confirmed the reported event that the spring was broken/fractured.Not all pieces were returned.A review of the device manufacturing records confirmed no abnormalities or deviations that could be related to the reported event.Review of the complaint history identified additional similar complaints for the reported item and the part and lot combination.A definitive root cause cannot 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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: OXFORD FEMORAL SLAP HAMMER
• Common Device Name: KNEE INSTRUMENT
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend
• Manufacturer (Section G): BIOMET UK LTD.; waterton industrial estates; bridgend
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 23297946
• Report Number: 3002806535-2025-00499
• Device Sequence Number: 4890175
• Product Code: LXH
• UDI-Device Identifier: 05019279129751
• UDI-Public: (01)05019279129751(10)ZB7082127
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/10/2026

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: 32-422365
• Device Lot Number: ZB7082127
• 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: 09/25/2025
• Supplement Date Received by Manufacturer: 12/01/2025; 02/09/2026
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 12/10/2025; 02/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/15/2022
• 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