BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIRSCHNER WIRE, DIAM.1.0X160MM, (10/PACKAGE)

    MDR report key: 1833327 · Received September 13, 2010

    Report

    Report Number
    8010177-2010-00308
    Event Type
    Malfunction
    Date Received
    September 13, 2010
    Date of Event
    August 11, 2010
    Report Date
    August 12, 2010
    Manufacturer
    STRYKER OSTEOSYNTHESIS FREIBURG
    Product Code
    JEY
    PMA / PMN Number
    K022185
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IN PROCESS, BUT NOT YET COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "KWIRE BROKE AS DRILL BIT PASSED OVER THE WIRE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KIRSCHNER WIRE, DIAM.1.0X160MM, (10/PACKAGE) IMPLANT JEY STRYKER OSTEOSYNTHESIS FREIBURG NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR