MAUDE Adverse Event Report: BIOMET UK LTD. OXF MP 10DEG FMRL DRL GD XL; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	32-422978
Medical Device Problem Codes	Material Separation (1562); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery, a plastic fragment detached from the oxford xl drill guide and entered the surgical site.The drill guide had already been used and was not required for the remainder of the procedure, allowing surgery to continue as planned.The fragment was successfully removed during the procedure.No complications, serious injury, or death were reported.The instrument had been used approximately 50 times before the event.Attempts have been made, and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).G2: foreign - event occurred in australia.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

• Brand Name: OXF MP 10DEG FMRL DRL GD XL
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer (Section G): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 25649225
• Report Number: 3002806535-2026-00227
• Device Sequence Number: 20302908
• Product Code: LXH
• UDI-Device Identifier: 05019279439973
• UDI-Public: (01)05019279439973(10)421330
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/29/2026

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: 32-422978
• Device Lot Number: 421330
• 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: 06/03/2026
• Initial Report FDA Received Date: 06/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown