BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORE IMPACTION DRILL

    MDR report key: 3021591 · Received March 26, 2013

    Report

    Report Number
    0001811755-2013-00604
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    February 28, 2013
    Report Date
    February 28, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    DZJ
    PMA / PMN Number
    K040369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON DISASSEMBLY FOR VISUAL INSPECTION CORROSION WAS FOUND ON THE BEARING, NOSE CONE AND SPINDLE HOUSING. ADDITIONALLY THE ROTOR AND THE MOTOR WERE SEIZED TOGETHER.

    Description of Event or Problem · 1

    WHILE TESTING THE CORE IMPACTION DRILL, IT WAS REPORTED THAT THE DEVICE HEATED UP. THIS EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE, SO THERE WAS NO PATIENT INVOLVEMENT. THERE WAS NO USER INJURY REPORTED AND NO ADVERSE CONSEQUENCES ALLEGED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123627 CORE IMPACTION DRILL DRIVER, WIRE, AND BONE DRILL, MANUAL DZJ STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1