BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORE IMPACTION DRILL

    MDR report key: 2851390 · Received October 29, 2012

    Report

    Report Number
    1811755-2012-03938
    Event Type
    Malfunction
    Date Received
    October 29, 2012
    Date of Event
    October 1, 2012
    Report Date
    October 1, 2012
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    DZJ
    PMA / PMN Number
    K040369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON DISASSEMBLY, CORROSION WAS DISCOVERED ON THE DRIVESHAFT AND BEARINGS, AS WELL AS THE CONTACT PINS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CORE IMPACTION DRILL HEATED UP DURING A PROCEDURE. A BACK-UP DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT OR USER INJURIES, AND NO ADVERSE CONSEQUENCES.

    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