MAUDE Adverse Event Report: ARTHREX, INC. DRIVER, T10 HEXALOBE, SHORT, BEVELED FT; ORTHOPEDIC MANUAL SURG INSTR

Model Number	DRIVER, T10 HEXALOBE, SHORT, BEVELED FT
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported during the screw extraction surgery that the driver twisted when unscrewing a screw.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
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The reported event was confirmed as one unpackaged ar-8741-40s, driver, t10 hexalobe, short, beveled ft, batch number 1392132, was received for investigation and upon visual inspection, it was observed that the hexalobe tip of the device is heavily twisted and therefore partly broken off (see evaluation pictures 3 + 4).Functional testing was not performed due to the damage of the device.No fragments were returned for evaluation.The most likely cause for the reported failure can be attributed to user error of the device due to over-torquing the screw.

• Brand Name: DRIVER, T10 HEXALOBE, SHORT, BEVELED FT
• 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: 23696587
• Report Number: 1220246-2025-05309
• Device Sequence Number: 9123739
• Product Code: LXH
• UDI-Device Identifier: 00888867362642
• UDI-Public: (01)00888867362642(11)210921(10)1392132
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• 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): 12/18/2025

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: DRIVER, T10 HEXALOBE, SHORT, BEVELED FT
• Device Catalogue Number: AR-8741-40S
• Device Lot Number: 1392132
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2025
• Supplement Date Received by Manufacturer: 11/28/2025
• Initial Report FDA Received Date: 12/02/2025
• Supplement Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/21/2021
• 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