BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QWIX SCREW, UNK

    MDR report key: 3964278 · Received June 19, 2014

    Report

    Report Number
    9615741-2014-00031
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    May 30, 2014
    Report Date
    May 30, 2014
    Manufacturer
    NEWDEAL SAS
    Product Code
    HWC
    PMA / PMN Number
    K050346
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT AVAILABLE FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A LEFT FOOT "FUSION BASED SECOND METATARSAL AND INTERMEDIATE CUNEIFORM WITH T PLATE AND RE APPROXIMATION FIRST/SECOND METATARSAL LIZ FRANC SEPARATION, THE SURGEON INSERTED THE 4.3 QWIX SCREW INTO NORMAL BONE (IT WAS NOT HARD OR DENSE) AND THE SCREW SPLIT LENGTHWISE. WHEN THE SURGEON TRIED TO REMOVE THE SCREW, IT BROKE INTO 3 PIECES. THE SURGEON USED A SCREW REMOVAL SET TO REMOVE THE SCREW AND SCREW HEAD. THE SCREW WAS DISCARDED. THE SURGERY WAS COMPLETED WITH A 5.5 QWIX SCREW." THE SURGERY WAS DELAYED 1 HR. THERE WAS NO ADVERSE CONSEQUENCES TO THE PT, REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360959 QWIX SCREW, UNK NA HWC NEWDEAL SAS

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR IMPLANT SCREW FROM QWIXIMP TRAY LOT QWIX34-044