MAUDE Adverse Event Report: ARTHREX, INC. 5.0MM, DRL BIT, CANNULATED, REUSABLE; DRILL BIT

Model Number	5.0MM, DRL BIT, CANNULATED, REUSABLE
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event was confirmed as one unpackaged ar-8770-02-ru, 5.0mm, drl bit, cannulated, reusable, batch number 916440, was received for investigation.Upon visual inspection, it was observed that an ar-8737-56 guide wire plunger is stuck inside the cannula (see evaluation pictures 3 + 5).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 due to misaligned insertion and/or prying/leveraging the device during use.
Event or Problem Description
It was reported that during a foot surgery the drill bit broke off.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.Update 12-may-2026: during incoming inspection of the returned devices, it was found that the initially provided complaint information was incorrect.During the visual evaluation it was found that the drill bit became stuck inside the guide and no part of the device broke off.

• Brand Name: 5.0MM, DRL BIT, CANNULATED, 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: 25283487
• Report Number: 1220246-2026-02993
• Device Sequence Number: 9777423
• Product Code: HTW
• UDI-Device Identifier: 00888867319592
• UDI-Public: (01)00888867319592(11)241030(10)916440
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Report Date (Section B): 05/26/2026

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: 5.0MM, DRL BIT, CANNULATED, REUSABLE
• Device Catalogue Number: AR-8770-02-RU
• Device Lot Number: 916440
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2026
• Initial Report FDA Received Date: 05/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/30/2024
• 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