MAUDE Adverse Event Report: BIOMET MICROFIXATION "1.5MM" SYSTEM TWIST DRILL; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Catalog Number	01-6951
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).E1: full establishment address - (b)(6).G2: foreign - the event occurred in japan.H6: proposed annex g code - mechanical (g04) - drill.The customer has indicated that the product is in the process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.If any further information is found that would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
It was reported that the drill fractured during a procedure.The fractured drill tip was recovered from the patient, and an alternate device was used to complete the surgery.No complications, injuries, or surgical interventions were required, and no foreign bodies were retained due to this malfunction.Attempts have been made, and no further information has been provided.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, g6, h2, h3, h4, h6, h11.No product was returned.A visual inspection was conducted on the customer provided picture.The picture shows signs of attempted use including marking and scratching on the drill surface.Further inspection shows the drill has fractured near where the fluted portion of the drill meets the drill base.The complaint is confirmed.A determination cannot be made as to what caused the drill to fracture.Review of the certs identified no deviations or anomalies during manufacturing.A supplier dhr review was not conducted as material cert confirms that the material and hardness of the instrument meet specification requested as certs shows.A definitive root cause cannot be determined.The reported event is confirmed, based on provided photos.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: "1.5MM" SYSTEM TWIST DRILL
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
• 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: 21905928
• Report Number: 0001032347-2025-00196
• Device Sequence Number: 8623141
• Product Code: HBE
• UDI-Device Identifier: 00841036012229
• UDI-Public: (01)00841036012229(10)354806
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2025

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: 01-6951
• Device Lot Number: 354806
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2025
• Supplement Date Received by Manufacturer: 07/31/2025
• Initial Report FDA Received Date: 04/24/2025
• Supplement Report FDA Received Date: 07/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/13/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown