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
Complaint is confirmed.Visual evaluation identified that the hex drive geometry at the distal tip of the returned t20 hexalobe driveshaft, solid, straight had twisted.Functional testing was not performed due to the damaged distal tip of the device.The most likely cause is attributed to user error of the device due to over-torquing/over-engaging the driver within the screw head.

• 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: 20460916
• Report Number: 1220246-2024-08144
• Device Sequence Number: 7718978
• Product Code: LXH
• UDI-Device Identifier: 00888867309814
• UDI-Public: (01)00888867309814(11)230829(10)1392329
• 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): 01/10/2025

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: 1392329
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2024
• Supplement Date Received by Manufacturer: 12/13/2024
• Initial Report FDA Received Date: 10/16/2024
• Supplement Report FDA Received Date: 01/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2023
• 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