MAUDE Adverse Event Report: ARTHREX, INC. DRILL, CANNULATED, FOR AC REPAIR, 2.4MM; DRILL BIT

Model Number	DRILL, CANNULATED, FOR AC REPAIR, 2.4MM
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On 13-jan-2026, it was reported by an arthrex subsidiary employee via (b)(4) that an ar-2257d-24 drill inner tube loosened and a bone fragment became stuck inside the drill.This occurred during use in a case with no patient effect.No significant surgery delay reported.
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.Complaint allegation is not confirmed.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 of the reported failure can be attributed to user error with the device due to excessive force during misalignment, or prying/leveraging the device during insertion.

• Brand Name: DRILL, CANNULATED, FOR AC REPAIR, 2.4MM
• 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: 24240747
• Report Number: 1220246-2026-00362
• Device Sequence Number: 21077809
• Product Code: HTW
• UDI-Device Identifier: 00888867026421
• UDI-Public: (01)00888867026421(11)250509(17)300430(10)15434159
• 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
• Report Date (Section B): 05/13/2026

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: DRILL, CANNULATED, FOR AC REPAIR, 2.4MM
• Device Catalogue Number: AR-2257D-24
• Device Lot Number: 15434159
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 01/12/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2026
• Supplement Date Received by Manufacturer: 05/12/2026
• Initial Report FDA Received Date: 02/02/2026
• Supplement Report FDA Received Date: 05/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/09/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown