BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO DRILL MEDIUM STRAIGHT ATTACHMENT

    MDR report key: 2132375 · Received June 13, 2011

    Report

    Report Number
    1811755-2011-02148
    Event Type
    Malfunction
    Date Received
    June 13, 2011
    Date of Event
    May 13, 2011
    Report Date
    May 17, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K040300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    EXCESSIVE DEBRIS WAS FOUND INSIDE THE DEVICE. MICRO DRILL MEDIUM STRAIGHT ATTACHMENT WAS DISCARDED; IT IS NOT A REPAIRABLE DEVICE.

    Description of Event or Problem · 1

    THE MICRO DRILL MEDIUM STRAIGHT ATTACHMENT WAS SENT FOR EVALUATION DUE TO OVERHEATING DURING A PROCEDURE. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. NO ADVERSE EVENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRO DRILL MEDIUM STRAIGHT ATTACHMENT ERL STRYKER INSTRUMENTS KALAMAZOO 11026

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK