BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QWIX FIXATION SCREW 4.3MM DIAMETER X 42MM LENGTH

    MDR report key: 4200036 · Received October 21, 2014

    Report

    Report Number
    9615741-2014-00055
    Event Type
    Malfunction
    Date Received
    October 21, 2014
    Date of Event
    September 29, 2014
    Report Date
    September 29, 2014
    Manufacturer
    NEWDEAL S.A.
    Product Code
    HWC
    PMA / PMN Number
    K050346
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES INVOLVED IN THE REPORTED INCIDENT HAVE NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    IT WAS REPORTED A 4.3 X 45 MML QWIX SCREW WAS PLACED IN THE (PT'S) LEFT 5TH METATARSAL. ONCE THE SCREW WAS PLACED IT WAS NOTICED THAT THE SCREW WAS BENT AT THE DISTA THREADS. THE SURGEON DECIDED TO REMOVE THE SCREW. WHEN THE SURGEON ATTEMPTED TO REMOVE THE SCREW, THREAD HEAD BROKE OFF. IT TOOK THE SURGEON APPROXIMATELY 1.5 HRS TO REMOVE THE REMAINDER OF THE SCREW WHICH ENDED UP BREAKING TO 2 SPOTS. THE SCREW WAS DISCARDED. THE SURGERY WAS REVISED TO A TSF FOREFOOT. THERE WAS NO REPORTED INJURY TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669846 QWIX FIXATION SCREW 4.3MM DIAMETER X 42MM LENGTH QUIX HWC NEWDEAL S.A.

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention (B)(4) (TX 8 DRIVER, NON CANNULATED W/AO)