MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD MP 04MM DRILL; BIT, DRILL

Catalog Number	32-423228
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a surgical procedure, the drill fractured into two parts, and a piece of the distal portion became lodged in the patient¿s bone.The surgeon determined that attempting to retrieve the broken fragment could risk additional bone damage; therefore, it was left in place.The procedure then continued as planned.No further patient impact or adverse consequences have been reported to date.Due diligence is in progress for this complaint; no further information or product has been received at the time of this report.
Additional Manufacturer Narrative
(b)(4).G2 - foreign: (b)(6).The customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d9, g3, g6, h2, h3, h6, h11.Product was returned for investigation.The product exhibited signs of use, including marring of the quick-connect feature and a nick on the remaining flute edge.The drill bit was observed to be fractured, and not all fragments were returned for evaluation.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.Complaints are monitored per complaint trending process.A definitive root cause could not 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 is available at the time of this report.

• Brand Name: OXFORD MP 04MM DRILL
• Common Device Name: BIT, DRILL
• 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: 23837075
• Report Number: 3002806535-2025-00650
• Device Sequence Number: 4993129
• Product Code: HTW
• UDI-Device Identifier: 00880304504707
• UDI-Public: (01)00880304504707(10)Z19D1726
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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): 04/23/2026

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: 32-423228
• Device Lot Number: Z19D1726
• 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: 11/25/2025
• Supplement Date Received by Manufacturer: 04/21/2026
• Initial Report FDA Received Date: 12/18/2025
• Supplement Report FDA Received Date: 04/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/27/2019
• 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