BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORE IMPACTION DRILL

    MDR report key: 3792108 · Received May 6, 2014

    Report

    Report Number
    0001811755-2014-01623
    Event Type
    Malfunction
    Date Received
    May 6, 2014
    Date of Event
    April 10, 2014
    Report Date
    April 10, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    DZJ
    PMA / PMN Number
    K040369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS AVAILABLE FOR EVALUATION BUT HAS NOT YET BEEN RECEIVED. ADDITIONAL INFORMATION MAY BE SUBMITTED ONCE THE DEVICE IS RECEIVED AND THE QUALITY INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THE DATE OF THE PRODUCT RETURN WAS PROVIDED. THE TECHNICIAN DUPLICATED THE REPORTED EVENT OF HEATING UP AND NOTED THAT THE DRIVESHAFT BEARING WAS DAMAGED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO A PROCEDURE AT THE USER FACILITY THE CORE IMPACTION DRILL WAS OVERHEATING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO A PROCEDURE AT THE USER FACILITY, THE CORE IMPACTION DRILL WAS OVERHEATING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270327 CORE IMPACTION DRILL DRIVER, WIRE, AND BONE DRILL, MANUAL DZJ STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1