MAUDE Adverse Event Report: BIOMET MICROFIXATION DRILL 1.5X115MM 37MM STP J-NT; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Catalog Number	01-9203
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported during an orthognathic procedure, that the drill fractured.There was no patient injury as a result of the malfunction.
Additional Manufacturer Narrative
(b)(4).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 follow-up report is being submitted to relay additional information and/or corrected information.Updated: g3, h2, h3, h4, h6, h11.H6 - suggested component code- mechanical (g04) ¿ drill.Reported event was unable to be confirmed due to limited information received from the customer and product was not returned.Certification was reviewed and no discrepancies related to the reported event were found.A definitive root cause cannot 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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information and/or corrected information.Updated: b5; h2; h11.No product was returned.However, examination of the provided pictures confirmed the reported product identification.Once photo shows the drill is clearly fractured, near the start of the fluted portion of the drill.The complaint is confirmed.The additional information does not change the root cause.A definitive root cause cannot 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
It was reported during an orthognathic procedure, that the drill fractured.The fractured pieces were removed from the patient's surgical site and no pieces were retained.Further, there was no patient injury as a result of the malfunction.

• Brand Name: DRILL 1.5X115MM 37MM STP J-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: 21457568
• Report Number: 0001032347-2025-00099
• Device Sequence Number: 8189238
• Product Code: HBE
• UDI-Device Identifier: 00841036017026
• UDI-Public: (01)00841036017026(10)417514
• Combination Product (Y/N): N
• Initial Reporter Country: CS
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/26/2025

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
• Device Catalogue Number: 01-9203
• Device Lot Number: 417514
• 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: 01/30/2025
• Supplement Date Received by Manufacturer: 06/03/2025; 08/08/2025
• Initial Report FDA Received Date: 02/25/2025
• Supplement Report FDA Received Date: 07/02/2025; 08/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/03/2023
• 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 Age: 50 YR
• Patient Sex: Male