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	Break (1069)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2023, it was reported by a sales representative via email that an ar-18800-25 driver shaft broke during the insertion of the 2.7mm screw.The bone socket was prepared with a 2.0mm drill, the screw was inserted with power, and the driver tip broke when it hit the plate.All the broken fragments were retrieved and confirmed via x-ray that nothing was left behind in the patient.Another ar-18800-25 driver shaft was used to continue the implantation of the screw.This was discovered during a tibia orif procedure on (b)(6) 2023.
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.
Additional Manufacturer Narrative
Complaint allegation is not 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.
Event or Problem Description
Additional information received on 7/11/2023: the ar-18800-25 driver shaft was attached to a 4400-battery power from another manufacturer.The case was not delayed, and the patient was not affected.
Additional Manufacturer Narrative
Additional information: b5, h3, h6.

• 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: emily shafer ; 8009337001
• MDR Report Key: 17480001
• Report Number: 1220246-2023-07448
• Device Sequence Number: 11395777
• Product Code: LXH
• UDI-Device Identifier: 00888867385603
• UDI-Public: 00888867385603
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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,Followup
• Report Date (Section B): 11/21/2024

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, T10, NON-RETAINING
• Device Catalogue Number: AR-18800-25
• Device Lot Number: 1392239
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2023
• Supplement Date Received by Manufacturer: 10/08/2024; Not provided
• Initial Report FDA Received Date: 08/08/2023
• Supplement Report FDA Received Date: 10/18/2024; 11/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/14/2022
• 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