MAUDE Adverse Event Report: BIOMET MICROFIXATION 1.8X50MM DRILL 26MM STP; DRILLS, BURRS

Catalog Number	24-2050
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported during the procedure, that two (2) drill bits fractured during use.A third drill bit was used to complete the procedure.There was no patient injury or delay in procedure as a result of the malfunction.
Additional Manufacturer Narrative
(b)(4).G2 - report source - foreign - japan.H6 - suggested component code - mechanical (g04) - drill.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 an initial procedure, two (2) drill bits fractured.A third drill bit was utilized to complete the procedure.All fractured fragments were recovered.The surgical technique specified for this device was followed.The drill bits had been used multiple times.No patient injury or delay to the procedure was reported as a result of this malfunction.It was reported that no further information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: b4; b5; d2; d4; d9; d10; g1; g3; g6; h1; h2; h3; h4; h5; h8; h10.Correction to h8.D10: concomitant medical products, part (lot): 24-2050 (354507).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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; d2; g1; g3; g6; h1; h2; h3; h6.The complaint can be confirmed through the returned product analysis.A visual inspection was conducted on the two returned drill bits.Both drill bits show signs of use, including marking and scratching on the drill surfaces.Further inspection also shows that both drills have fractured.A dimensional analysis was completed, and both drills are conforming.The device history record was reviewed, and no discrepancies relevant to the reported event were found.The root cause has been identified as use error; the device is indicated for single use only, and it was confirmed to have been reused.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 is available at the time of this report.

• Brand Name: 1.8X50MM DRILL 26MM STP
• Common Device Name: DRILLS, BURRS
• 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: 22437463
• Report Number: 0001032347-2025-00255
• Device Sequence Number: 16953411
• Product Code: HBE
• UDI-Device Identifier: 00841036059279
• UDI-Public: (01)00841036059279(10)354507
• 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): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/10/2025

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: 24-2050
• Device Lot Number: 354507
• 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: 06/11/2025
• Supplement Date Received by Manufacturer: 10/09/2025; 12/10/2025
• Initial Report FDA Received Date: 07/08/2025
• Supplement Report FDA Received Date: 11/05/2025; 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/07/2020
• 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: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: H11
• Patient Sex: Unknown