MAUDE Adverse Event Report: BIOMET MICROFIXATION DRILL 1.6X50MM 22MM STOP; DRILLS, BURRS, TREPHINES & ACCESSORIES

Catalog Number	46-1006
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).G2: foreign, event occurred in japan.H6: component code, mechanical (g04), drill.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 during surgery the drill tip fractured.The fractured tip was embedded in the patient's bone but was retrieved.This occurred with two drill bits and a spare drill was used to complete the procedure.During the procedure, the surgeon connected the drill bits to a competitor's motor and the drill's cutting capacity was perceived to be weak.The surgeon applied tension, and the tips broke during bone insertion.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information and/or corrected information.Updated: e1, e2, e3, g3, h1 and h2.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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information and/or corrected information.Updated: d4, d9, g3, h1, h2, h3, h4, h6, h10 and h11.Complaint sample was evaluated, and the reported event was confirmed.An investigation was conducted on the two returned 46-1006 twist drills.Both drills show signs of attempted use including marking and scratching on the drill surfaces.Further inspection shows that both drills have fractured at the same location, near where the fluted portion of the drill meets the drill base.A dimensional analysis was conducted on both drills at the fracture location, and both drills were found to be conforming.The complaint for both drills is confirmed.A determination cannot be made as to what caused the drills to fracture.Dhr was reviewed and no discrepancies related to the reported event were found.Root cause was unable to 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: DRILL 1.6X50MM 22MM STOP
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES
• 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: 23943222
• Report Number: 0001032347-2026-00001
• Device Sequence Number: 18129359
• Product Code: HBE
• UDI-Device Identifier: 00888233009522
• UDI-Public: (01)00888233009522(10)339566
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/27/2026

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: 46-1006
• Device Lot Number: 339566
• 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: 12/08/2025
• Supplement Date Received by Manufacturer: 01/04/2026; 03/13/2026
• Initial Report FDA Received Date: 01/02/2026
• Supplement Report FDA Received Date: 01/23/2026; 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/03/2019
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown