BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUAL SPEED CEMENT INJECTION GUN

    MDR report key: 3789625 · Received May 5, 2014

    Report

    Report Number
    0001811755-2014-01602
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Date of Event
    April 11, 2014
    Report Date
    April 11, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    JDZ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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

    BASED ON THE MANUFACTURING ENGINEER¿S EVALUATION OF THE DEVICE, THE CAUSE WAS DETERMINED TO BE THE ROD CATCHING ON THE BUSHINGS DUE TO INTERFERENCE. THE DEVICE WAS REPAIRED AND RETURNED TO THE USER FACILITY.

    Description of Event or Problem · 1

    DURING INSPECTION AT THE USER FACILITY THE DUAL SPEED CEMENT INJECTION GUN WAS PRODUCING METAL SHAVINGS. IT WAS REPORTED THAT THERE WAS NO ASSOCIATED PROCEDURE. NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT.

    Description of Event or Problem · 1

    DURING INSPECTION AT THE USER FACILITY, THE DUAL SPEED CEMENT INJECTION GUN WAS PRODUCING METAL SHAVINGS. IT WAS REPORTED THAT THERE WAS NO ASSOCIATED PROCEDURE. NO PATIENT INVOLVEMENT, 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
    267658 DUAL SPEED CEMENT INJECTION GUN MIXER, CEMENT, FOR CLINICAL USE JDZ STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1