MAUDE Adverse Event Report: Biomet UK Ltd. OXF UNI PH3 TIB IMPACTOR; Driver, Prosthesis

Catalog Number	32-420932
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the black impactor piece is broken.They flagged it before the start of the surgery.The broken impactor did not contact the patient.Over 100 instruments were used before the reported failure.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).G2: foreign - event occurred in canada.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.

• Brand Name: OXF UNI PH3 TIB IMPACTOR
• Common Device Name: Driver, Prosthesis
• 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 ; +1(574)526-0384
• MDR Report Key: 50912420
• Report Number: 3002806535-2026-00352
• Device Sequence Number: 17593362
• Product Code: HWR
• UDI-Device Identifier: 05019279905638
• 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): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/28/2026

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: 32-420932
• Device Lot Number: ZB7367082
• 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: 09/04/2026
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/01/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown