MAUDE Adverse Event Report: ARTHREX, INC. DRILL NON-CANNULATED, 4MM; DRILL BIT

Model Number	DRILL NON-CANNULATED, 4MM
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2026
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 surgery, the drill was blunt.There was no harm for patient, operator or third party reported.No further information was received.Update 09-mar-2026 - further information was received: it was reported that during the latarjet surgery, the drill was blunt.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with the same device was used anyway.It was not necessary to switch the surgical technique or do a second surgery.

• Brand Name: DRILL NON-CANNULATED, 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: 24559136
• Report Number: 1220246-2026-01324
• Device Sequence Number: 13117212
• Product Code: HWE
• UDI-Device Identifier: 00888867004450
• UDI-Public: (01)00888867004450(11)250425(10)128932
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• 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): 05/05/2026

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 NON-CANNULATED, 4MM
• Device Catalogue Number: AR-1204D
• Device Lot Number: 128932
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 02/11/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2026
• Supplement Date Received by Manufacturer: 05/04/2026
• Initial Report FDA Received Date: 03/10/2026
• Supplement Report FDA Received Date: 05/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/25/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown