BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AWL, CURVED

    MDR report key: 1638887 · Received March 17, 2010

    Report

    Report Number
    9610622-2010-00117
    Event Type
    Malfunction
    Date Received
    March 17, 2010
    Date of Event
    February 23, 2010
    Report Date
    February 24, 2010
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    HWJ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NA

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "THEY WERE USING THE AWL TO DO THE REMOVAL OF GAMMA NAIL. REMOVING BONE FROM THE PROXIMAL FEMUR AND THE TIP OF THE AWL BENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AWL, CURVED INSTRUMENT HWJ STRYKER OSTEOSYNTHESIS KIEL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other