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)
Date of Event	11/27/2025
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that the tibial lid of an impactor broke during use and no fragments were retained in the patient.There were no consequences or impact to the patient.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: b4, b5, d9, g3, g6, h2, h3, h4, h6, h11.The reported event was confirmed by a review of pictures.The product (main body) involved in the reported event was returned for investigation.The device exhibited signs of use, including scratches and dings.The product ( pad ) involved in the reported event was not returned for investigation; however, pictures were provided and reviewed.The images appear to show the impaction pad separated into two sections, with surface wear, including dents and scratches, visible.Based on the available images, no additional assessment can be made.A review of the device manufacturing records confirmed no abnormalities or deviations.Review of the complaint history identified additional similar complaints for the reported item, and no additional similar complaints for the reported 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: OXF UNI PH3 TIB IMPACTOR
• Common Device Name: DRIVER, PROSTHESIS
• 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: 23801131
• Report Number: 3002806535-2025-00615
• Device Sequence Number: 15380343
• Product Code: HWR
• UDI-Device Identifier: 05019279905638
• UDI-Public: (01)05019279905638(10)ZB6682974
• 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
• Report Date (Section B): 05/18/2026

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: ZB6682974
• 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: 11/27/2025
• Supplement Date Received by Manufacturer: 05/18/2026
• Initial Report FDA Received Date: 12/15/2025
• Supplement Report FDA Received Date: 05/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/27/2020
• 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