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	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 11/08/2024, it was reported by a sales representative via (b)(4) that an ar-18800-03 driver shaft and ar-18800-04 driver shaft ends are twisted.This occurred during use in a case with no patient effect.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint allegation is confirmed.Upon visual inspection, it was noted that the drive geometry at the distal tip of the returned driver shaft, t6, ao had twisted.Functional testing was not performed due to the damaged distal tip of the device.The most likely cause for the reported failure can be attributed to user error of the device due to over-torquing/over-engaging the inserter within the screw during use.

• 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: 20863535
• Report Number: 1220246-2024-08731
• Device Sequence Number: 12902878
• Product Code: LXH
• UDI-Device Identifier: 00888867385566
• UDI-Public: (01)00888867385566(11)240319(10)1392411
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 01/29/2025

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
• Device Lot Number: 1392411
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2024
• Supplement Date Received by Manufacturer: 01/03/2025
• Initial Report FDA Received Date: 12/06/2024
• Supplement Report FDA Received Date: 01/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2024
• 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