BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORE IMPACTION DRILL

    MDR report key: 2771420 · Received September 28, 2012

    Report

    Report Number
    1811755-2012-03681
    Event Type
    Malfunction
    Date Received
    September 28, 2012
    Date of Event
    August 9, 2012
    Report Date
    September 11, 2012
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    DZJ
    PMA / PMN Number
    K040369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DUE TO THE DEVICE NOT POWERING UP DURING EVAL AT THE MFR, THE CUSTOMER'S COMPLAINT REGARDING OVERHEATING COULD NOT BE CONFIRMED. HOWEVER, DAMAGED BEARINGS AND CORROSION WITHIN THE MOTOR WERE DISCOVERED, WHICH CAN CAUSE OVERHEATING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN EXTRACTION PROCEDURE AT THE USER FACILITY, THE DRILL WAS HEATING UP. 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