MAUDE Adverse Event Report: ARTHREX, INC. SCREWDRIVER, T10 HEXALOBE; ORTHOPEDIC MANUAL SURG INSTR

Model Number	SCREWDRIVER, T10 HEXALOBE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2026
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 16-jan-2026, a facility representative reported via (b)(4) that an ar-8943-08 t10 hexalobe screwdriver tip broke during a hardware removal case.The tip that broke was not recovered.X-rays were taken to ensure it was not left in the patient.The driver was replaced, and the case continued with no adverse effects to the patient.Additional information was received on 20-jan-2026.The rep advised that no attachment or adapter was used, and that the 3.5 mm headless compression screw was being removed by hand via the ar-8943-08.

• Brand Name: SCREWDRIVER, T10 HEXALOBE
• 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: 24277856
• Report Number: 1220246-2026-00445
• Device Sequence Number: 13227133
• Product Code: LXH
• UDI-Device Identifier: 00888867052185
• UDI-Public: (01)00888867052185(10)6790928
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2026

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: SCREWDRIVER, T10 HEXALOBE
• Device Catalogue Number: AR-8943-08
• Device Lot Number: 6790928
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2026
• Supplement Date Received by Manufacturer: 05/12/2026
• Initial Report FDA Received Date: 02/06/2026
• Supplement Report FDA Received Date: 05/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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