MAUDE Adverse Event Report: ARTHREX, INC. DRIVER SHAFT, T7 HEXALOBE CANNULATED; MANUAL INSTR, GENERAL SURGICAL

Model Number	DRIVER SHAFT, T7 HEXALOBE CANNULATED
Medical Device Problem Codes	Break (1069); Defective Device (2588)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that according to the operating surgeon, there is a material defect in the screwdriver, because the device was used today and is now defective.No further information was provided.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
Update avoe 08-nov-2024.It was confirmed that during a metal-removal surgery one screwdriver broke off while the screw was being pulled out.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.All metall parts could be removed from the patient.
Additional Manufacturer Narrative
Additional information: b5, d9, g3, h3, h6.The complaint allegation is confirmed.Upon visual inspection, it was noted that the drive geometry of the distal tip was broken off.(damage) functional testing was not performed due to the damage to the device.It was not indicated if a torque-indicating adapter had been used with the device.The most likely cause of the reported and observed failure is user error.Specifically, the error involved applying excessive force, leading to over-torquing or over-engaging the driver within the screw head.

• Brand Name: DRIVER SHAFT, T7 HEXALOBE CANNULATED
• Common Device Name: MANUAL INSTR, GENERAL SURGICAL
• 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: 20524413
• Report Number: 1220246-2024-08253
• Device Sequence Number: 20825500
• Product Code: LXH
• UDI-Device Identifier: 00888867197268
• UDI-Public: 00888867197268
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2024

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, T7 HEXALOBE CANNULATED
• Device Catalogue Number: AR-8610D-25
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2024
• Supplement Date Received by Manufacturer: 11/08/2024
• Initial Report FDA Received Date: 10/24/2024
• Supplement Report FDA Received Date: 12/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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