MAUDE Adverse Event Report: BIOMET MICROFIXATION TRAUMAONE SYSTEM; DRILLS, BURRS, TREPHINES & ACCESSORIES

Catalog Number	46-1004
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that staff identified a fractured drill before surgery during preparation for an initial procedure.The drill had been used multiple times, and the fracture was present before sterilization, while still at the hospital.The device was reported to have been used as a loaner and was returned to the distributor following use.An alternate device was used to complete the procedure.Attempts have been made, and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information and/or corrected information.Updated: b5, d9, g3, h2, h3, h6 and h11.Complaint sample was evaluated, and the reported event was confirmed.An investigation was conducted on the returned drill.The pictures show signs of attempted use including marking and scratching on the drill surface.Further inspection shows a clear fracture of the drill near where the fluted portion of the drill tip meet the drill base.A dimensional analysis was conducted, and product was found to be conforming.A determination cannot be made as to what caused the drill to fracture.Dhr was reviewed and no discrepancies related to the reported event were found.The root cause of the reported issue is attributed to a user error.It was reported that the drill had been used multiple times, and the fracture was found before sterilization prior to surgery.Per the instructions for use, the device is single use only and should not be re-sterilized.A summary of the investigation was sent to the complainant conveying proper surgical technique and use of the device.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: TRAUMAONE SYSTEM
• 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: 22088121
• Report Number: 0001032347-2025-00218
• Device Sequence Number: 18109472
• Product Code: HBE
• UDI-Device Identifier: 00841036128029
• UDI-Public: (01)00841036128029(10)327608
• 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): 09/18/2025

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: 46-1004
• Device Lot Number: 327608
• 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: 04/28/2025
• Supplement Date Received by Manufacturer: 09/12/2025
• Initial Report FDA Received Date: 05/27/2025
• Supplement Report FDA Received Date: 09/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/29/2019
• 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