BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORE IMPACTION DRILL

    MDR report key: 4121339 · Received September 26, 2014

    Report

    Report Number
    0001811755-2014-03385
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    August 29, 2014
    Report Date
    September 2, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K112593
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECHNICIAN WAS ABLE TO DUPLICATE THE REPORTED HEAT, AND NOTED THAT THE DRIVESHAFT ASSEMBLY WAS CORRODED. THE DEVICE CAN EXHIBIT A HEAT SYMPTOMS IF THE DRIVESHAFT ASSEMBLY IS AFFECTED BY CORROSION. THEREFORE, IT IS LIKELY THE REPORTED EVENT WAS CAUSED BY THE CORRODED DRIVESHAFT ASSEMBLY.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION IN PROGRESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CORE IMPACTION DRILL WAS HEATING UP DURING THE COURSE OF PROCEDURE AT THE USER FACILITY. NO ADVERSE CONSEQUENCES, NO MEDICAL INTERVENTION, AND NO SURGICAL DELAY WERE REPORTED WITH THIS EVENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CORE IMPACTION DRILL WAS HEATING UP DURING THE COURSE OF PROCEDURE AT THE USER FACILITY. NO ADVERSE CONSEQUENCES, NO MEDICAL INTERVENTION, AND NO SURGICAL DELAY WERE REPORTED WITH THIS EVENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602040 CORE IMPACTION DRILL DRILL, SURGICAL, ENT (ELECTRIC OR PNUMATIC) INCLUDING HANDPIECE ERL STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1