MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD CMNTLS IMPLANT INSERT; KNEE INSTRUMENT

Catalog Number	32-422097
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/25/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).G2: foreign - event occurred in sweden.The 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.
Event or Problem Description
It was reported that during the surgical procedure, a portion of the oxford tibial impactor broke and was left in situ.There are no plans to remove the broken fragment, and no revision surgery was performed.The patient is in good general health and is not affected by the retained fragment.No further surgical intervention or follow-up is planned.Attempts have been made, and no further information has been provided.
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, h6, h11.The following section was corrected: h6 (component code).The reported event was confirmed by review of pictures and x-rays.The product involved in the reported event was not returned for investigation; however, pictures were provided and review identified that the tip of the instrument fractured.Radiographs were provided and reviewed by a radiologist.The review identified a single lateral view of the knee which shows postoperative changes of unicompartmental knee arthroplasty.There is soft tissue air suggestive of early post-operative status.A metallic foreign body projects over the posterior knee joint space.The device history record was reviewed and no discrepancies relevant to the reported event were found.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
It was reported that during a surgical procedure, a portion of a tibial impactor broke and the fragment remained in situ.Intra-operatively, the fragment was left in place, no revision surgery was performed, and there were no plans for removal or further surgical intervention or follow-up.The patient experienced no consequences or impact.Attempts have been made and no further information has been provided.

• Brand Name: OXFORD CMNTLS IMPLANT INSERT
• 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: 23508802
• Report Number: 3002806535-2025-00533
• Device Sequence Number: 9622022
• Product Code: NRA
• UDI-Device Identifier: 00880304525672
• UDI-Public: (01)00880304525672(11)161124(10)ZB160805
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: P010014
• 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): 04/15/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 32-422097
• Device Lot Number: ZB160805
• Was Device Available for Evaluation?: No
• 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: 10/15/2025
• Supplement Date Received by Manufacturer: 04/15/2026
• Initial Report FDA Received Date: 11/10/2025
• Supplement Report FDA Received Date: 04/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/24/2016
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown