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	09/05/2022
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 9/7/2023, it was reported by a sales representative via (b)(4) that an ar-18800-03 self retaining drive shaft and an ar-18800-04 non-retaining driver shaft had an issue.While inserting a cortical screw, the ar-18800-03 self retaining drive shaft started to torq out and wasn't retaining screws.The device was switched to an ar-18800-04 non-retaining driver shaft, and while inserting another screw, the driver's head broke off inside the screw head.The piece was recovered, and the case was completed by switching to a solid blue handle t6 driver in the trauma mini frag tray 2.0 screw caddy.This was discovered during a met shaft fracture procedure on (b)(6) 2023, with no reported patient harm.Additional information received on 9/19/2023: there was a 1-5 minute delay in the procedure.
Additional Manufacturer Narrative
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, 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: emily shafer ; 8009337001
• MDR Report Key: 17890291
• Report Number: 1220246-2023-08098
• Device Sequence Number: 17877212
• Product Code: LXH
• UDI-Device Identifier: 00888867385573
• UDI-Public: 00888867385573
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 10/25/2024

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: 1392241
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2023
• Supplement Date Received by Manufacturer: 10/09/2024
• Initial Report FDA Received Date: 10/06/2023
• Supplement Report FDA Received Date: 10/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/11/2022
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown