MAUDE Adverse Event Report: ARTHREX, INC. COUNTERSINK, 3.0MM, CANNULATED; MANUAL INSTR, GENERAL SURGICAL

Model Number	COUNTERSINK, 3.0MM, CANNULATED
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On 05-jan-2025, it was reported by an arthrex subsidiary employee via (b)(4) that an ar-8737-24 cannulated countersink broke during a knee arthroscopy procedure.It was reported that at the moment of drilling, the drill broke inside the patient's joint, and all fragments of the drill were removed.The instrument technician reported that the drill likely came into contact with another screw that was already inserted in the patient.The patient's bone quality was reported as hard.The case was completed successfully with a second drill that was available and no patient harm.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.

• Brand Name: COUNTERSINK, 3.0MM, CANNULATED
• 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: 24115692
• Report Number: 1220246-2026-00250
• Device Sequence Number: 20330445
• Product Code: MDM
• UDI-Device Identifier: 00888867046191
• UDI-Public: 00888867046191
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: COUNTERSINK, 3.0MM, CANNULATED
• Device Catalogue Number: AR-8737-24
• Device Lot Number: 1392412
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2026
• Supplement Date Received by Manufacturer: 05/12/2026
• Initial Report FDA Received Date: 01/20/2026
• Supplement Report FDA Received Date: 05/13/2026
• 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