BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VADER PEDICLE SYSTEM TORQUE WRENCH

    MDR report key: 18534700 · Received January 18, 2024

    Report

    Report Number
    3006493760-2024-00001
    Event Type
    Malfunction
    Date Received
    January 18, 2024
    Report Date
    January 18, 2024
    Manufacturer
    ICOTEC AG
    Product Code
    NKB
    UDI-DI
    07640164844589
    PMA / PMN Number
    K222789
    Removal / Correction Number
    Z-0700-2024
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1676939 VADER PEDICLE SYSTEM TORQUE WRENCH VADER PEDICLE SYSTEM NKB ICOTEC AG 42-702 07640164844589

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown