MAUDE Adverse Event Report: ARTHREX, INC. 2.5MM DRILL BIT, CALIBRATED, REUSABLE

Model Number	2.5MM DRILL BIT, CALIBRATED, REUSABLE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
It was reported that during a distal tibia fracture surgery, the drill bit broke off.All broken pieces were retrieved out of the patient.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6 the reported event was confirmed as one unpackaged ar-8943-42-ru, 2.5mm drill bit, calibrated, reusable, batch number 916439, was received for investigation and the evaluation revealed that the drill is broken off (see evaluation pictures 1 + 2).Functional testing was not performed due to the damage of the device.The most likely cause for the reported failure can be attributed to user error of the device due to prying/leveraging the device during use.Further the cutting edge is caved / dull (see evaluation picture 3).

• Brand Name: 2.5MM DRILL BIT, CALIBRATED, REUSABLE
• Common Device Name: DRILL BIT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 23567654
• Report Number: 1220246-2025-05078
• Device Sequence Number: 21364512
• Product Code: HTW
• UDI-Device Identifier: 00888867265769
• UDI-Public: (01)00888867265769(11)240709(10)916439
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2026

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: 2.5MM DRILL BIT, CALIBRATED, REUSABLE
• Device Catalogue Number: AR-8943-42-RU
• Device Lot Number: 916439
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2025
• Supplement Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 11/17/2025
• Supplement Report FDA Received Date: 02/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/09/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown