BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORE IMPACTION DRILL

    MDR report key: 2853947 · Received October 24, 2012

    Report

    Report Number
    1811755-2012-03873
    Event Type
    Malfunction
    Date Received
    October 24, 2012
    Date of Event
    October 1, 2012
    Report Date
    October 2, 2012
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    DZJ
    PMA / PMN Number
    K040369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE DEVICE EVALUATION, THE UPPER END OF THE ROTOR WAS FOUND TO BE DAMAGED, AND THE BEARINGS ON THE DRIVESHAFT ASSEMBLY AS WELL AS THE BEARINGS ON THE ROTOR ASSEMBLY WERE NOT TURNING SMOOTHLY, WHICH ARE PROBABLE CAUSES OF THE REPORTED OVERHEATING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE AT THE USER FACILITY THE DRILL WAS OVERHEATING. BACK-UP EQUIPMENT WAS USED TO COMPLETE THE PROCEDURE. NO DELAY, NO ADVERSE CONSEQUENCES AND NO MEDICAL INTERVENTION WERE REPORTED.

    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