MAUDE Adverse Event Report: ARTHREX, INC. 1.70MM DRILL FOR FIBERTAK; DRILL BIT

Model Number	1.70MM DRILL FOR FIBERTAK
Medical Device Problem Codes	Break (1069); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, it was reported by an arthrex subsidiary employee via sems-06886193 that an ar-3600d-3 drill was inserted into the ar-3600d and started drilling, it got stuck in the middle and when tried to force it out, the drill broke.This case was completed by using another product of same product number.No patient harms.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to user error of the device due to interference with the mating instrument and/or prying/leveraging the devices during use.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint allegation is confirmed.Visual inspection of the drill, for fibertak¿ 1.7 mm, identified that the tip of the mating part is stuck at the distal end of the shaft.Functional testing was not performed due to the damage to the device.The method the quality of the bone encountered was not specified.The most likely cause for the reported failure can be attributed to user error of the device due to improper bone preparation, misalignment insertion, and/or prying/leveraging of the device during insertion.

• Brand Name: 1.70MM DRILL FOR FIBERTAK
• 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: 22144518
• Report Number: 1220246-2025-02379
• Device Sequence Number: 8340278
• Product Code: HTW
• UDI-Device Identifier: 00888867101920
• UDI-Public: 00888867101920
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Followup
• Report Date (Section B): 12/19/2025

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: 1.70MM DRILL FOR FIBERTAK
• Device Catalogue Number: AR-3600D-3
• Device Lot Number: 15131895
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2025
• Supplement Date Received by Manufacturer: 10/01/2025; 12/17/2025
• Initial Report FDA Received Date: 06/04/2025
• Supplement Report FDA Received Date: 10/08/2025; 12/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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