MAUDE Adverse Event Report: ARTHREX, INC. DRIVER SHAFT, T4, SELF RETAINING,MINI AO; ORTHOPEDIC MANUAL SURG INSTR

Model Number	DRIVER SHAFT, T4, SELF RETAINING,MINI AO
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 09/20/2024, it was reported by an arthrex employee via (b)(4) that an ar-18700-09 driver shaft was twisted.This occurred during a case that carried on and was completed successfully with backup parts.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: 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 for the reported failure can be attributed to user error of the device due to over-torquing/over-engaging the driver with the screw head.

• Brand Name: DRIVER SHAFT, T4, SELF RETAINING,MINI 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: 20426726
• Report Number: 1220246-2024-08094
• Device Sequence Number: 20958904
• Product Code: LXH
• UDI-Device Identifier: 00888867313781
• UDI-Public: (01)00888867313781(11)200702(10)1392025
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2025

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: DRIVER SHAFT, T4, SELF RETAINING,MINI AO
• Device Catalogue Number: AR-18700-09
• Device Lot Number: 1392025
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2024
• Supplement Date Received by Manufacturer: 06/10/2025
• Initial Report FDA Received Date: 10/11/2024
• Supplement Report FDA Received Date: 07/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/02/2020
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown