BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    K-WIRE DIA 2.5XL270MM

    MDR report key: 5022486 · Received August 20, 2015

    Report

    Report Number
    9615741-2015-00043
    Event Type
    Malfunction
    Date Received
    August 20, 2015
    Date of Event
    June 2, 2015
    Report Date
    July 23, 2015
    Manufacturer
    NEWDEAL SAS
    Product Code
    HWC
    PMA / PMN Number
    K071639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE WAS THE WRONG LENGTH FOR THE SET IT WAS CONTAINED IN. DURING A TRIPLE ARTHRODESIS A LARGE GUIDE PIN FOR LARGE QWIX SET WAS GRABBED OUT OF SET AND ONE OF THE LARGER, THICKER WIRES WAS THE WRONG LENGTH FOR THE SET. IT WAS REPORTED THE DEVICE WAS IN USE FOR THIS EVENT; HOWEVER, THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    552192 K-WIRE DIA 2.5XL270MM NA HWC NEWDEAL SAS

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR