MAUDE Adverse Event Report: ARTHREX, INC. DRIVER SHAFT, T6, SELF RETAINING, AO; ORTHOPEDIC MANUAL SURG INSTR

Model Number	DRIVER SHAFT, T6, SELF RETAINING, AO
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
On 04/16/2024, it was reported by a sales representative via (b)(4) that (2) ar-18800-03 driver shafts and (2) ar-18800-04 driver shafts were warped and breaking.This occurred during an orif ankle procedure on (b)(6) 2024.No additional information was provided, and additional information has been asked.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Complaint allegation is 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 is attributed to user error of the device due to over-torquing/over-engaging the driver within the screw head.

• Brand Name: DRIVER SHAFT, T6, SELF RETAINING, 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: 19278018
• Report Number: 1220246-2024-03020
• Device Sequence Number: 20413145
• Product Code: LXH
• UDI-Device Identifier: 00888867385566
• UDI-Public: 00888867385566
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 01/03/2025

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, T6, SELF RETAINING, AO
• Device Catalogue Number: AR-18800-03
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2024
• Supplement Date Received by Manufacturer: 12/09/2024
• Initial Report FDA Received Date: 05/09/2024
• Supplement Report FDA Received Date: 01/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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