MAUDE Adverse Event Report: BIOMET MICROFIXATION TW DRILL 1.1X50MM 5MMSTOP W/NT; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a drill broke during use.The fragments were recovered.No fragments remain in the patient's body.
Additional Manufacturer Narrative
Zimmer biomet (b)(4).G2: foreign source: japan.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.
Additional Manufacturer Narrative
This report is being submitted to update additional information in sections b4, b5, e1, e2, e3, g3, g6, h2, h11.
Event or Problem Description
No further event information is available at the time of this report.
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.H6: component code: mechanical (g04) ¿ drill.No product was returned.A visual inspection was conducted on the customer provided pictures.The pictures show signs of attempted use including marking and scratching on the drill surface.Further inspection shows that the drill has fractured.The fractured tip shows very heavy marking and scratching on its surface.The complaint is confirmed.A determination cannot be made as to what caused the drill tip to fracture.Review of the certs identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined.The reported event is confirmed, based on provided photos.If any further information is found that would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.This report is being submitted to update additional information in sections b4, b5, g3, g6, h2, h3, h4, and h11.

• Brand Name: TW DRILL 1.1X50MM 5MMSTOP W/NT
• 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: 20662418
• Report Number: 0001032347-2024-00342
• Device Sequence Number: 8502955
• Product Code: HBE
• UDI-Device Identifier: 00841036013141
• UDI-Public: (01)00841036013141(10)361489
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/28/2025

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 Model Number: N/A
• Device Catalogue Number: 01-7142
• Device Lot Number: 361489
• Was Device Available for Evaluation?: No
• 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: 10/21/2024
• Supplement Date Received by Manufacturer: 12/04/2024; 02/27/2025
• Initial Report FDA Received Date: 11/12/2024
• Supplement Report FDA Received Date: 12/16/2024; 02/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown