MAUDE Adverse Event Report: ARTHREX, INC. DRIVER SHAFT, T25 HEXALOBE, CANNULATED; MANUAL INSTR, GENERAL SURGICAL

Model Number	DRIVER SHAFT, T25 HEXALOBE, CANNULATED
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the ankle arthrodesis, the tip of the screwdriver twisted and broke off while the screw (6.5 mm headless compression screw) was being inserted.The broken pieces were retrieved from the patient.In addition, a guide wire (not an arthrex product) became lodged in the screwdriver.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with a different device.It was not necessary to switch the surgical technique or 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: DRIVER SHAFT, T25 HEXALOBE, 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: 25020946
• Report Number: 1220246-2026-02531
• Device Sequence Number: 9631838
• Product Code: LXH
• UDI-Device Identifier: 00888867197299
• UDI-Public: (01)00888867197299(11)240220(10)1392407
• Combination Product (Y/N): N
• Initial Reporter Country: LG
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2026

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: DRIVER SHAFT, T25 HEXALOBE, CANNULATED
• Device Catalogue Number: AR-8610D-65
• Device Lot Number: 1392407
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 04/09/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2026
• Supplement Date Received by Manufacturer: 06/23/2026
• Initial Report FDA Received Date: 04/28/2026
• Supplement Report FDA Received Date: 07/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/20/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown