BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORE IMPACTION DRILL

    MDR report key: 3811340 · Received May 15, 2014

    Report

    Report Number
    0001811755-2014-01775
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    April 18, 2014
    Report Date
    April 18, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    DZJ
    PMA / PMN Number
    K040369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECHNICIAN WAS ABLE TO DUPLICATE THE REPORTED EVENT AFTER REPLICATING THE ACCOUNT¿S STERILIZATION METHODS, WHICH DOES NOT INCLUDE AN AUTOCLAVE DRY CYCLE. ACCORDING TO A REVIEW OF THE RISK DOCUMENTS, THE DEVICE CAN OVERHEAT IF IT IS IMPROPERLY STERILIZED. THEREFORE, IT IS LIKELY THE REPORTED EVENT WAS CAUSED BY INSUFFICIENT DRY TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE AT THE USER FACILITY THE CORE IMPACTION DRILL WAS OVERHEATING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291218 CORE IMPACTION DRILL DRIVER, WIRE, AND BONE DRILL, MANUAL DZJ STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1