MAUDE Adverse Event Report: BIOMET MICROFIXATION TW DRILL 1.1X105MM 18MM STP; FLUTED SURGICAL DRILL BIT, REUSABLE

Catalog Number	01-7149
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).G2: japan.H6: proposed annex g code: mechanical (g04) ¿ drill.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 tip of the drill was fractured and retrieved during a procedure.Another drill was used to complete the procedure.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d4, d9, g3, g6, h3, h6, h11.Complaint can be confirmed through the returned product analysis.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.A visual inspection was conducted on the returned drill.The drill shows signs of attempted use including marking on the drill tip.Further inspection shows that the drill tip has fractured near where the fluted portion of the tip meets the tip base.The device history record was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: TW DRILL 1.1X105MM 18MM STP
• Common Device Name: FLUTED SURGICAL DRILL BIT, REUSABLE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer (Section G): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 22541522
• Report Number: 0001032347-2025-00277
• Device Sequence Number: 20586484
• Product Code: HBE
• UDI-Device Identifier: 00841036013202
• UDI-Public: (01)00841036013202(10)355778
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K062842
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2025

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: 01-7149
• Device Lot Number: 355778
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2025
• Supplement Date Received by Manufacturer: 11/04/2025
• Initial Report FDA Received Date: 07/18/2025
• Supplement Report FDA Received Date: 11/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/13/2020
• 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