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

Model Number	DRIVER SHAFT, T6, NON-RETAINING, AO
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2024
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 09/26/2024, it was reported by a sales representative via (b)(4) that an ar-18800-04 driver shaft tip broke off inside the patient inside the screw head, and an ar-18800-04 driver shaft was warped.The case was not affected.This was discovered during a procedure on 09/19/2024, with no reported patient harm.Additional information has been requested.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint allegation is confirmed.One unpackaged ar-18800-04 driver shaft, t6 lot number: 1392346 was received for investigation.Visual evaluation noted that the hex of the device was twisted and it appeared that a piece of the tip was missing.The length of the returned device was measured using a caliper id: (b)(4) and it was found to be 3.5695, which is not in tolerance of the length specified in drawing c19299 of 3.600 ±.020, indicating that a fragment of around.44 had broken off.Functional testing was not performed due to the damage to the device.The most likely cause for the reported failure can be attributed to misuse/use error due to over-torquing and/or prying/leveraging the device during use.

• Brand Name: DRIVER SHAFT, T6, NON-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: 20471337
• Report Number: 1220246-2024-08183
• Device Sequence Number: 7613059
• Product Code: LXH
• UDI-Device Identifier: 00888867385573
• UDI-Public: (01)00888867385573(11)231206(10)1392346
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 01/23/2025

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, NON-RETAINING, AO
• Device Catalogue Number: AR-18800-04
• Device Lot Number: 1392346
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2024
• Supplement Date Received by Manufacturer: 12/31/2024
• Initial Report FDA Received Date: 10/17/2024
• Supplement Report FDA Received Date: 01/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2023
• 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