MAUDE Adverse Event Report: ICOTEC AG VADER PEDICLE SYSTEM TORQUE WRENCH

Model Number	42-702
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The inspection of further torque wrench devices by the supplier showed a sporadic untight welding seam, which allowed liquids (e.G.Cleaning or disinfection agents) and/or steam to enter the inside of the torque wrench during processing.Thus leading to corrosion of the mechanical components, leading to malfunction of the torque limiting function over time.The reason for the partial untight seam welding is the process of welding and subsequent polishing.Icotec has decided to recall all torque wrench devices ref 42-702 as a precautionary measure.
Event or Problem Description
A torque wrench was returned from an hospital.During internal testing of the device, it was detected that the torque limiting function of the wrench was not functioning correctly.The torque wrench is used to final tighten the nut screws of the icotec pedicle systems during implantation.

• Brand Name: VADER PEDICLE SYSTEM TORQUE WRENCH
• Common Device Name: VADER PEDICLE SYSTEM
• Manufacturer (Section D): ICOTEC AG; industriestrasse 12; altstaetten, sg 9450 ; SZ 9450
• Manufacturer (Section G): ICOTEC AG; industriestrasse 12; altstaetten, sg 9450 ; SZ 9450
• Manufacturer Contact: joerg schneider ; industriestrasse 12; altstaetten, sg 9450 ; SZ 9450
• MDR Report Key: 18534700
• Report Number: 3006493760-2024-00001
• Device Sequence Number: 7587488
• Product Code: NKB
• UDI-Device Identifier: 07640164844589
• UDI-Public: 07640164844589
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K222789
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Remedial Action: Notification,Recall
• Type of Report: Initial
• Report Date (Section B): 01/18/2024

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: 42-702
• Device Catalogue Number: 42-702
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/21/2023
• Initial Report FDA Received Date: 01/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0700-2024
• Patient Sequence Number: 1
• Patient Sex: Unknown