BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORE IMPACTION DRILL

    MDR report key: 2974634 · Received January 17, 2013

    Report

    Report Number
    1811755-2013-90111
    Event Type
    Malfunction
    Date Received
    January 17, 2013
    Date of Event
    December 21, 2012
    Report Date
    December 21, 2012
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    DZJ
    PMA / PMN Number
    K040369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE SUBMITTED ONCE THE DEVICE IS RECEIVED AND THE QUALITY INVESTIGATION IS COMPLETED, IF ADDITIONAL INFORMATION IS OBTAINED AND REQUIRES REPORTING. THE REASON FOR THE SERIALIZATION STARTING WITH 90XXX IS TO PROVIDE CLARIFICATION FOLLOWING A CHANGE IN STRYKER'S ELECTRONIC COMPLAINT SYSTEMS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE AT THE USER FACILITY, THE DRILL WAS OVERHEATING. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE WITHOUT A DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27307 CORE IMPACTION DRILL DZJ STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK