BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO DRILL MEDIUM STRAIGHT ATTACHEMENT

    MDR report key: 2665154 · Received July 12, 2012

    Report

    Report Number
    1811755-2012-02654
    Event Type
    Malfunction
    Date Received
    July 12, 2012
    Date of Event
    May 28, 2012
    Report Date
    July 5, 2012
    Manufacturer
    STRYKER INSTRUMENTS, INSTRUMENTS DIV.
    Product Code
    ERL
    PMA / PMN Number
    K040300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CORROSION WAS NOTED WITHIN THE DEVICE. THE DEVICE WAS NOT RETURNED TO THE USER FACILITY; IT IS NOT REPAIRABLE ONCE IT IS DISASSEMBLED.

    Description of Event or Problem · 1

    A MICRO DRILL MEDIUM STRAIGHT ATTACHMENT WAS SENT FOR SERVICE AND IT OVERHEATED DURING PERFORMANCE TESTING. NO ADVERSE EVENT WAS ASSOCIATED WITH THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRO DRILL MEDIUM STRAIGHT ATTACHEMENT ERL STRYKER INSTRUMENTS, INSTRUMENTS DIV. 11026

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK