MAUDE Adverse Event Report: ARTHREX, INC. DRIVER SHAFT, T10, NON-RETAINING; ORTHOPEDIC MANUAL SURG INSTR

Model Number	DRIVER SHAFT, T10, NON-RETAINING
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 09/12/2024, a sales representative reported via (b)(6) that an ar-18800-25 driver shaft warped during a case.The case was completed using a backup driver in the tray, and there was no delay.This was discovered during a foot and ankle reconstruction procedure on (b)(6) 2024, with no reported patient harm.Additional information has been requested.
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.The complaint allegation is confirmed.One unpacked ar-18800-25 serial/batch number (b)(6) was received for investigation.Visual inspection found that the hex tip of the driver was twisted.It was noted that the laser marks are fading most likely because the reprocessing of the device.Functional testing could not be performed due to the damage of the device.The most likely cause is attributed to misuse due to use error of over-torquing/over-engaging the driver with the screw head.

• Brand Name: DRIVER SHAFT, T10, NON-RETAINING
• 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: 20382759
• Report Number: 1220246-2024-08013
• Device Sequence Number: 8037364
• Product Code: LXH
• UDI-Device Identifier: 00888867385603
• UDI-Public: (01)00888867385603(11)221227(10)1392247
• 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): 01/15/2025

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: DRIVER SHAFT, T10, NON-RETAINING
• Device Catalogue Number: AR-18800-25
• Device Lot Number: 1392247
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2024
• Supplement Date Received by Manufacturer: 12/20/2024
• Initial Report FDA Received Date: 10/07/2024
• Supplement Report FDA Received Date: 01/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/27/2022
• 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