MAUDE Adverse Event Report: ARTHREX, INC. T25 HEXALOBE, ISO, CANN.; ORTHOPEDIC MANUAL SURG INSTR

Model Number	T25 HEXALOBE, ISO, CANN.
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, it was reported by a sales representative via (b)(4) that (qty.3) of an ar-8770-01 t25 hexalobe drivers broke upon insertion of the 7.0 headless xl screws.The tips of each driver snapped off while trying to implant the screws for a medial calcaneal slide during a stage 2 flatfoot procedure.This was discovered during the case with no patient harm.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Complaint allegation is not confirmed.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause of this failure is attributed to wear and tear damage incurred over repeatedly torquing/engaging the driver within the screw head and extended use in the field.Manufacturing date 2023.

• Brand Name: T25 HEXALOBE, ISO, CANN.
• 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: 22337597
• Report Number: 1220246-2025-02674
• Device Sequence Number: 9060309
• Product Code: LXH
• UDI-Device Identifier: 00888867263789
• UDI-Public: (01)00888867263789(11)230103(10)1392252
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 09/30/2025

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: T25 HEXALOBE, ISO, CANN.
• Device Catalogue Number: AR-8770-01
• Device Lot Number: 1392252
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2025
• Supplement Date Received by Manufacturer: 09/26/2025
• Initial Report FDA Received Date: 06/26/2025
• Supplement Report FDA Received Date: 09/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/03/2023
• 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