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

Model Number	DRIVER, T10 HEXALOBE, BEVELED FT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On 23-jan-2026, it was reported by a sales representative via (b)(4) that an ar-8741-40 driver broke.This occurred during use in a case with no patient effect.No broken fragments left inside the patient.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: b5, g3.
Event or Problem Description
Additional information provided on 29-jan-2026: it was further reported this occurred during an mis bunion case when implanting the 3.5 mm beveled screws.It was reported that when implanting the screw on the screwdriver, it completely snapped and the surgeon extracted the broken piece.A 10-minute case delay was experienced.

• Brand Name: DRIVER, T10 HEXALOBE, 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: 24315115
• Report Number: 1220246-2026-00534
• Device Sequence Number: 5650195
• Product Code: LXH
• UDI-Device Identifier: 00888867362635
• UDI-Public: (01)00888867362635(11)241203(10)1392447
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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,Followup
• Report Date (Section B): 05/18/2026

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, BEVELED FT
• Device Catalogue Number: AR-8741-40
• Device Lot Number: 1392447
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2026
• Supplement Date Received by Manufacturer: 01/29/2026; 05/14/2026
• Initial Report FDA Received Date: 02/11/2026
• Supplement Report FDA Received Date: 02/23/2026; 05/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/03/2024
• 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