MAUDE Adverse Event Report: ARTHREX, INC. 2.0MM DRILL BIT, CALIBRATED, REUSABLE

Model Number	2.0MM DRILL BIT, CALIBRATED, REUSABLE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/19/2024
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 pilon fracture, anterolateral access surgery while drilling the first hole for the screw through the locking drill guide the drill did break.The surgeon suggest that he drills against the reposition k-wire and that why the drill broke.He left the broken off piece of the drill inside the bone under the cortical of the bone.For the fixation of screws he used another holes in the plate.The surgery was finished successfully with another drill from the instrument set.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
The complaint allegation is confirmed.One unpackaged ar-8943-16-ru serial/batch number (b)(6) was received for evaluation.A visual evaluation found that the device tip was broken off.Functional testing was not performed due to the damage to the instrument.The most likely reason for the reported failure is user error, specifically allowing the device to make contact with other instruments during use.

• Brand Name: 2.0MM 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: 21168348
• Report Number: 1220246-2025-09485
• Device Sequence Number: 14536930
• Product Code: HTW
• UDI-Device Identifier: 00888867265752
• UDI-Public: (01)00888867265752(11)220721(10)032229
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2025

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: 2.0MM DRILL BIT, CALIBRATED, REUSABLE
• Device Catalogue Number: AR-8943-16-RU
• Device Lot Number: 032229
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2024
• Supplement Date Received by Manufacturer: 03/28/2025
• Initial Report FDA Received Date: 01/16/2025
• Supplement Report FDA Received Date: 04/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2022
• Is the Device Labeled for Single Use? (Y/N): No
• 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