BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECTA C SELF RETRAINING SCREWDRIVER

    MDR report key: 4503936 · Received February 9, 2015

    Report

    Report Number
    3006639916-2015-00013
    Event Type
    Malfunction
    Date Received
    February 9, 2015
    Date of Event
    January 6, 2015
    Report Date
    February 6, 2015
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    SZ
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE SURGEON HAS MISTAKENLY EXPANDED THE SCREW TOO EARLY AND THEN HAD TRIED TO PUT A SCREW IN THE PLATE WITH FORCE. BOTH SCREWDRIVERS WERE BROKEN (OF THE SAME LOT AND CODE). THE OPERATION WAS SUCCESSFULLY COMPLETED WITH THE RESCUE SCREWDRIVER. MFR REF #: 3005180920-2015-00013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89860 MECTA C SELF RETRAINING SCREWDRIVER SURGICAL INSTRUMENT FOR SPINE LXH MEDACTA INTERNATIONAL SA 1316455

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK NOTE:2 ITEMS OF THE SAME LOT # AND CATALOG # ARE,| INVOLVED.