BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORE IMPACTION DRILL

    MDR report key: 2140736 · Received June 15, 2011

    Report

    Report Number
    1811755-2011-02167
    Event Type
    Malfunction
    Date Received
    June 15, 2011
    Date of Event
    May 6, 2011
    Report Date
    May 6, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    DZJ
    PMA / PMN Number
    K040369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CORE IMPACTION DRILL IS A LOANER DEVICE AND IT WAS REPAIRED AND PUT BACK INTO CIRCULATION.

    Description of Event or Problem · 1

    THE LOANER CORE IMPACTION DRILL WAS SENT FOR SVC 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 CORE IMPACTION DRILL DZJ STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK