BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CALCLOCK

    MDR report key: 1264587 · Received November 12, 2008

    Report

    Report Number
    3005039508-2008-00008
    Event Type
    Malfunction
    Date Received
    November 12, 2008
    Date of Event
    October 21, 2008
    Report Date
    October 21, 2008
    Manufacturer
    ORTHOHELIX SURGICAL DESIGNS, INC.
    Product Code
    KTT
    PMA / PMN Number
    K061400
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    SURGEON WAS UNABLE TO PROPERLY ENGAGE LOCKING SCREW THREADS INTO PLATE TO CREATE LOCK; THEY DIDN'T CROSS-THREAD, BUT JUST KEPT SPINNING. THIS WAS THE "WORST CALC CASE" THE SURGEON HAD EVER DONE BEFORE AND HAD A VOID LARGER THAN A GOLF BALL IN THE CALCANEO'S BONE. THE SURGEON'S FIRST SCREW WAS IN THE SLOT AND SECOND INTO A LOCKING HOLE. HE THREADED THE LOCKING DRILL GUIDE INTO THE PLATE WITH NO PROBLEM, FOLLOWED BY DRILLING WITH A .062" K-WIRE, FOLLOWED BY HAND DRILLING WITH PROVIDED BIT. ONCE THE SCREW WAS PLACED IN THE DRILLED HOLE, IT'S HEAD DROPPED ALL THE WAY TO THE PLATE INDICATING THE LACK OF BONE AROUND THE SCREW. THE SURGEON COULD NOT GET THIS SCREW TO LOCK INTO THE PLATE. THE SURGEON REMOVED THIS PLATE AND TRIED A SECOND PLATE. PRIOR TO THE TECH HANDING IT TO THE SURGEON, IT WAS VERIFIED THAT LOCKING SCREWS LOCKED INTO THE 2 LOCKING HOLES PROPERLY, AND THEY DID . THE SURGEON PROCEEDED TO PLACE 2ND PLATE ON THE BONE IN THE SAME POSITION AS THE 1ST PLATE AND HAD SAME ISSUE ACHIEVING PROPER ANGLE EVEN THOUGH VERBAL AND VISUAL AID WAS BEING GIVEN TO THE SURGEON OF THE PROPER ANGLE BETWEEN SCREW AND PLATE. THE SURGEON WAS ABLE TO LOCK THE SECOND LOCKING HOLE BUT NOT THE FIRST BECAUSE HE USED NO SCREW IN THIS HOLE. THE SURGEON THOUGHT THE PATIENT WOULD BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CALCLOCK FRACTURE REPAIR PLATE AND SCREW KTT ORTHOHELIX SURGICAL DESIGNS, INC. CAT-001-LR L450

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention