BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOANER CORE IMPACTION DRILL

    MDR report key: 3994325 · Received August 8, 2014

    Report

    Report Number
    0001811755-2014-02816
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    July 14, 2014
    Report Date
    July 14, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K112593
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FAILURE FOR HEAT WAS CONFIRMED THROUGH FUNCTIONAL EVALUATION, DISASSEMBLY, AND VISUAL INSPECTION. THROUGH VISUAL INSPECTION, THE TECHNICIAN CONFIRMED THE BEARINGS WERE CORRODED. THE DEVICE WAS REPAIRED AND PLACED BACK INTO STRYKER STOCK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE AT THE USER FACILITY THE LOANER CORE IMPACTION DRILL WAS OVERHEATING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING BACK-UP EQUIPMENT WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467787 LOANER CORE IMPACTION DRILL DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1