BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GAMMA DRILL, 5.5MM

    MDR report key: 481396 · Received August 28, 2003

    Report

    Report Number
    9610622-2003-00031
    Event Type
    Malfunction
    Date Received
    August 28, 2003
    Date of Event
    July 3, 2003
    Report Date
    July 29, 2003
    Manufacturer
    STRYKER HOWMEDICA KIEL TRAUMA GMBH
    Product Code
    HTW
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THE TIP OF THE DRILL SHEARED OFF AS IT WAS GOING THROUGH THE NAIL. THE DRILL WAS RETRIEVED ALONG WITH THE BROKEN PIECE, EXCEPT FOR ONE SMALL PIECE, ABOUT 1MM X 2MM, WHICH WAS INTRAOSSEOUS AND COULD NOT BE RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GAMMA DRILL, 5.5MM INSTRUMENT HTW STRYKER HOWMEDICA KIEL TRAUMA GMBH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other