MAUDE Adverse Event Report: ARTHREX, INC. T20 HEXALOBE DRIVER, STRAIGHT (AO); ORTHOPEDIC MANUAL SURG INSTR

Model Number	T20 HEXALOBE DRIVER, STRAIGHT (AO)
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2024
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 09/24/2024, it was reported by a sales representative via (b)(4) that (2) ar-8970-08 t20 hexalobe driveshafts were warped.This occurred during a foot & ankle fusion on (b)(6) 2024 where the case was completed using a backup driver in the tray.There was no delay in the case.
Additional Manufacturer Narrative
Visual evaluation of the customer-provided pictures noted an ar-8970-08 t20 hexalobe driveshafts were warped.Refer to attachments.The complaint allegation is confirmed based on the customer-provided pictures.Based on the information provided, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to user error of the device due to over-torquing the screw when inserting into the plate and/or hard bone.

• Brand Name: T20 HEXALOBE DRIVER, STRAIGHT (AO)
• 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: 20460943
• Report Number: 1220246-2024-08143
• Device Sequence Number: 18084041
• Product Code: LXH
• UDI-Device Identifier: 00888867309814
• UDI-Public: (01)00888867309814(11)211101(10)1392144
• 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): 08/15/2025

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: T20 HEXALOBE DRIVER, STRAIGHT (AO)
• Device Catalogue Number: AR-8970-08
• Device Lot Number: 1392144
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2024
• Supplement Date Received by Manufacturer: 08/15/2025
• Initial Report FDA Received Date: 10/16/2024
• Supplement Report FDA Received Date: 08/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2021
• 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