BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUAL SPEED CEMENT INJECTION GUN

    MDR report key: 3887226 · Received June 20, 2014

    Report

    Report Number
    0001811755-2014-02218
    Event Type
    Malfunction
    Date Received
    June 20, 2014
    Date of Event
    May 26, 2014
    Report Date
    May 26, 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

    THE RETURNED DEVICE WAS CONFIRMED TO BE PRODUCING METAL SHAVINGS. BASED ON THE MANUFACTURING ENGINEER¿S EVALUATION OF THE DEVICE, THE SOURCE OF THE METAL SHAVINGS WAS DETERMINED TO BE THE RAM BUSHINGS. THE DEVICE WAS REPAIRED AND RETURNED TO THE USER FACILITY.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 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

    IT WAS REPORTED THAT 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
    362648 DUAL SPEED CEMENT INJECTION GUN MIXER, CEMENT, FOR CLINICAL USE JDZ STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1