BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVOLUTION CEMENT GUN

    MDR report key: 3755652 · Received April 17, 2014

    Report

    Report Number
    0001811755-2014-01373
    Event Type
    Malfunction
    Date Received
    April 17, 2014
    Date of Event
    March 27, 2014
    Report Date
    March 27, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    JDZ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE FILED AFTER THE QUALITY INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    ONE OF THE TWO SCREWS AT THE DISTAL END OF THE CRADLE WAS CONFIRMED TO BE MISSING ON THE RETURNED DEVICE. THE DEVICE WAS REPAIRED AND RETURNED TO THE USER FACILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING A PROCEDURE THE REVOLUTION CEMENT GUN WAS FOUND TO HAVE A SCREW MISSING ON THE END. 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 FOLLOWING A PROCEDURE, THE REVOLUTION CEMENT GUN WAS FOUND TO HAVE A SCREW MISSING ON THE END. 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
    235095 REVOLUTION CEMENT GUN MIXER, CEMENT, FOR CLINICAL USE JDZ STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1