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	12/02/2025
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 a foot surgery the tip of the device broke off while using the device in the patient.All fragments were retrieved.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The reported event was confirmed as the visual evaluation of the received device showed a piece of the hex has broken off.The broken fragement itself was not returned.A function testing of the device was not performed due to the damages observed.The most likely cause for the reported failure can be attributed to user error due to user-applied excessive mechanical forces during insertion.

• 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: 23880060
• Report Number: 1220246-2025-05781
• Device Sequence Number: 15854353
• Product Code: LXH
• UDI-Device Identifier: 00888867197299
• UDI-Public: (01)00888867197299(11)220503(10)1392218
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2026

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: 1392218
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2025
• Supplement Date Received by Manufacturer: 04/08/2026
• Initial Report FDA Received Date: 12/23/2025
• Supplement Report FDA Received Date: 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/03/2022
• 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