BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTIVE HEX SCREWDRIVER

    MDR report key: 5303354 · Received September 20, 2004

    Report

    Report Number
    1057469-2004-00005
    Event Type
    Malfunction
    Date Received
    September 20, 2004
    Date of Event
    August 25, 2004
    Report Date
    September 17, 2004
    Manufacturer
    ENDIUS, INC.
    Product Code
    LRZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A CAPTIVE HEXTIP SCREWDRIVER BROKE WHILE THE SURGEON WAS TIGHTENING THE LAST CAP SCREW OF A SPINAL FIXATION SYSTEM. THE SURGEON ATTEMPTED TO REMOVE THE HEX TIP FROM THE CAP SCREW UNSUCCESSFULLY. THE TIP OF THE SCREWDRIVER REMAINED EMBEDDED IN THE CAPSCREW AND THE PATIENT WAS CLOSED. THE SCREWDRIVER IS MANUFACTURED WITH 440C STAINLESS STEEL BUT HAS NOT BEEN USED FOR IMPLANTS. THE CAPSCREW IS MADE FROM TITANIUM. THERE IS A POSSIBILITY OF INTERACTION/CORROSION DUE TO THE IMPLANTATION OF THESE DISSIMILAR METALS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPTIVE HEX SCREWDRIVER SCREWDRIVER LRZ ENDIUS, INC. NA L526718

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR