BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QWIX FIXATION SCREW 4.3MM DIABETER X 36MM LENGTH

    MDR report key: 3001705 · Received January 28, 2013

    Report

    Report Number
    9615741-2013-00001
    Event Type
    Malfunction
    Date Received
    January 28, 2013
    Date of Event
    January 9, 2013
    Report Date
    January 28, 2013
    Manufacturer
    NEWDEAL S.A.S.
    Product Code
    HWC
    PMA / PMN Number
    K071639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT EXPECTED TO BE RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SCREW HEAD BROKE OFF OF THE BODY OF THE SCREW DURING INSERTION OF THE SCREW THE BROKEN HEAD WAS REMOVED ALONG WITH THE SHAFT OF THE SCREW BUT THE DISTAL MOST THREADS OF THE SCREW REMAIN BROKEN OFF IN THE PT. EXTRA TIME WAS TAKEN TO ATTEMPT TO REMOVE THE ENTIRE SCREW WHICH WAS UNSUCCESSFUL. NO OTHERS SCREWS WERE USED. ADD'L INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37964 QWIX FIXATION SCREW 4.3MM DIABETER X 36MM LENGTH QUIX HWC NEWDEAL S.A.S.

    Patients

    Seq Age Sex Outcome Treatment
    1