BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORE IMPACTION DRILL

    MDR report key: 4110350 · Received September 23, 2014

    Report

    Report Number
    0001811755-2014-03337
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Date of Event
    August 27, 2014
    Report Date
    August 27, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K112593
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS IS IN PROGRESS; ADDITIONAL INFORMATION WILL BE SUBMITTED ONCE THE QUALITY INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    THE TECHNICIAN WAS UNABLE TO DUPLICATE THE REPORTED EVENT OF OVERHEATING, BUT NOTED THAT THE MOTOR ASSEMBLY WAS CORRODED. A CORRODED MOTOR ASSEMBLY CAN CAUSE THE REPORTED EVENT.

    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 USING BACK-UP EQUIPMENT. NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT.

    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 USING BACK-UP EQUIPMENT. NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591900 CORE IMPACTION DRILL DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1