BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QWIX FIXATION SCREW - 3MM DIAMETER X 34MM LENGTH

    MDR report key: 1712247 · Received May 28, 2010

    Report

    Report Number
    9615741-2010-00022
    Event Type
    Malfunction
    Date Received
    May 28, 2010
    Date of Event
    May 3, 2010
    Report Date
    May 28, 2010
    Manufacturer
    NEWDEAL S.A.
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION. PLEASE SEE ALSO MANUFACTURERS REPORT NUMBER 9615741-2010-00020 FOR THE DRILL BIT MALFUNCTION THAT OCCURRED DURING THE SAME PROCEDURE.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT DURING A LAPIDUS PROCEDURE FOR HALLUX VALGUS CORRECTION, THE SURGEON WAS INSERTING THE SCREW INTO THE BONE WHEN HE NOTICED PIECES OF THE DISTAL END OF THE SCREW BREAKING OFF. THE SURGEON REMOVED THE SCREW WITH A SCREWDRIVER AND PROCEEDED TO DRILL THE HOLE AGAIN USING A HAND DRILL. ALL FRAGMENTS WERE REMOVED FROM THE SURGICAL SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QWIX FIXATION SCREW - 3MM DIAMETER X 34MM LENGTH NONE HWC NEWDEAL S.A. TO BE DECIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR SET DRILL BIT ALSO BROKE.| QWIX LOWER EXTREMITY FIXATION SCREW INSTRUMENT