MAUDE Adverse Event Report: ARTHREX, INC. COUNTERSINK, FOR 6.5MM HCS; ORTHOPEDIC MANUAL SURG INSTR

Model Number	COUNTERSINK, FOR 6.5MM HCS
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/02/2025
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 an ankle fusion surgery the ar-8610cs-65 countersink broke during the procedure.While using the device correctly with the attached handle on the second turn the tip broke.Two small fragments remained in the patient.The surgeon continued with the screw insertion following the instrument breakage.The surgery was finished successfully.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint allegation is confirmed.Upon visual inspection, it was noted that one of the tips was broken off, and the countersink for 6.5 mm hcs other tips was damaged.Functional testing was not performed due to the damage to the device.The method of bone preparation and the quality of the bone encountered were not specified.The most likely cause of the reported failure is user error, specifically due to misaligned insertion or the application of excessive mechanical force during installation or use.

• Brand Name: COUNTERSINK, FOR 6.5MM HCS
• Common Device Name: ORTHOPEDIC MANUAL SURG INSTR
• 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: 22071167
• Report Number: 1220246-2025-02159
• Device Sequence Number: 8703291
• Product Code: LXH
• UDI-Device Identifier: 00888867197251
• UDI-Public: (01)00888867197251(11)230406(10)012308
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 08/04/2025

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, FOR 6.5MM HCS
• Device Catalogue Number: AR-8610CS-65
• Device Lot Number: 012308
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 05/02/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2025
• Supplement Date Received by Manufacturer: 07/31/2025
• Initial Report FDA Received Date: 05/22/2025
• Supplement Report FDA Received Date: 08/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/06/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown