MAUDE Adverse Event Report: ARTHREX, INC. DRILL, 2.75MM, .066 CANNULATION; MANUAL INSTR, GENERAL SURGICAL

Model Number	DRILL, 2.75MM, .066 CANNULATION
Medical Device Problem Code	Dull, Blunt (2407)
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
It was reported that during a surgery the device ar-7000-14 was broken/dull drill bit and the surgery was not a success.No further information was provided.Update 16-feb-2026: it was confirmed that the device was dull and not broken.The error occurred during a mini open latarjet surgery.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with another drill and some other screws that had another purpose and were not suited for this procedure.It was not necessary to do a second surgery.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.

• Brand Name: DRILL, 2.75MM, .066 CANNULATION
• Common Device Name: MANUAL INSTR, GENERAL SURGICAL
• 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: 24474497
• Report Number: 1220246-2026-01080
• Device Sequence Number: 21227924
• Product Code: MDM
• UDI-Device Identifier: 00888867040908
• UDI-Public: 00888867040908
• 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
• Report Date (Section B): 02/27/2026

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, 2.75MM, .066 CANNULATION
• Device Catalogue Number: AR-7000-14
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2026
• Initial Report FDA Received Date: 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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