BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORE IMPACTION DRILL

    MDR report key: 2042793 · Received March 30, 2011

    Report

    Report Number
    1811755-2011-01028
    Event Type
    Malfunction
    Date Received
    March 30, 2011
    Date of Event
    March 3, 2011
    Report Date
    March 3, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    DZJ
    PMA / PMN Number
    K040369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED FOR EVALUATION; ADDITIONAL INFORMATION WILL BE SUBMITTED ONCE THE QUALITY INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    A STRYKER CORE IMPACTION DRILL WAS SENT IN FOR REPAIR DUE TO OVERHEATING DURING A PROCEDURE. NO ADVERSE CONSEQUENCE WAS REPORTED; THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER DEVICE WITHOUT ANY PROCEDURE DELAY.

    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