BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORE IMPACTION DRILL

    MDR report key: 3612555 · Received February 7, 2014

    Report

    Report Number
    0001811755-2014-00394
    Event Type
    Malfunction
    Date Received
    February 7, 2014
    Date of Event
    January 9, 2014
    Report Date
    January 13, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    DZK
    PMA / PMN Number
    K040369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON DISASSEMBLY FOR VISUAL INSPECTION CORROSION WAS FOUND WITHIN THE DEVICE, THE MOTOR PINS WERE DAMAGED, A BEARING WAS STUCK ON THE ROTOR, THE DRIVESHAFT WAS STICKING, AND THE ROTOR COUPLER AND SPINDLE HOUSING WERE WORN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TESTING CONDUCTED AT THE USER FACILITY THE CORE IMPACTION DRILL WAS OVERHEATING. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING TESTING AT THE USER FACILITY, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    79537 CORE IMPACTION DRILL DRIVER, WIRE, AND BONE DRILL, MANUAL DZK STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1