MAUDE Adverse Event Report: ARTHREX, INC. DRIVER, T10 HEXALOBE; MANUAL INSTR, GENERAL SURGICAL

Model Number	DRIVER, T10 HEXALOBE
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2025
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
On 11/25/2025, it was reported by a sales representative via (b)(4) that an ar-8944dh driver tip was twisted.This was discovered during a procedure with no patient harm.Additional information provided on 12/2/2025: it was further reported that this occurred during a clavicle fracture procedure, and the case was completed with another driver.No patient harm or case delay was reported.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6 one unpackaged ar-8944dh batch 130964 was received for evaluation.Visual inspection revealed that the driver tip was twisted and bent.Functional testing was not performed due to the damage of the device.The most likely cause of the reported failure is user error with the device, resulting from over-torquing/over-engaging the inserter within the screw during use.The complaint allegation was confirmed.Refer to the investigation photos.

• Brand Name: DRIVER, T10 HEXALOBE
• 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: 23817023
• Report Number: 1220246-2025-05629
• Device Sequence Number: 21355338
• Product Code: MDM
• UDI-Device Identifier: 00888867053045
• UDI-Public: (01)00888867053045(11)240403(10)130964
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2026

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, T10 HEXALOBE
• Device Catalogue Number: AR-8944DH
• Device Lot Number: 130964
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2025
• Supplement Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 12/16/2025
• Supplement Report FDA Received Date: 02/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/03/2024
• 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