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	10/20/2025
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 10/20/2025, it was reported by a sales representative via (b)(4) that an ar-8741-40 driver, t10 hexalobe tip broke.This was discovered during the case.Debris was produced but the broken piece was retrieved with no patient harm.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.One unpackaged ar-8741-40, 3.5 mm beveled ft driver (batch 1392328), was received for investigation.Visual inspection identified a fractured tip and twisted threads.The observed damage is most consistent with off-axis loading and excessive force during use, potentially related to improper bone preparation and misaligned insertion, resulting in prying or levering of the device.The complaint allegation is confirmed.Refer to the investigation photographs.

• 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: 23390882
• Report Number: 1220246-2025-04830
• Device Sequence Number: 21335983
• Product Code: LXH
• UDI-Device Identifier: 00888867362635
• UDI-Public: (01)00888867362635(11)230726(10)1392328
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 02/19/2026

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: 1392328
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2025
• Supplement Date Received by Manufacturer: 02/17/2026
• Initial Report FDA Received Date: 10/27/2025
• Supplement Report FDA Received Date: 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/26/2023
• 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