BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVOLUTION CEMENT GUN

    MDR report key: 4840584 · Received June 12, 2015

    Report

    Report Number
    0001811755-2015-02109
    Event Type
    Malfunction
    Date Received
    June 12, 2015
    Date of Event
    May 15, 2015
    Report Date
    May 15, 2015
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    JDZ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT WAS NOT DUPLICATED; HOWEVER IT WAS CONFIRMED THROUGH COMPONENT INSPECTION. BASED ON A REVIEW OF THE RISK DOCUMENTATION, A POTENTIAL CAUSE FOR THE RAM BUSHINGS PRODUCING METALS SHAVINGS IS WEAR AT THE BUSHING/ROD INTERFACE. THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RECEIVED FOR EVALUATION AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE REVOLUTION CEMENT GUN WAS PRODUCING METAL SHAVINGS DURING CLEANING. NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT, AND THERE WAS NO ASSOCIATED PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE REVOLUTION CEMENT GUN WAS PRODUCING METAL SHAVINGS DURING CLEANING. NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT, AND THERE WAS NO ASSOCIATED PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385151 REVOLUTION CEMENT GUN CEMENT, MIXER, FOR CLINICAL USE JDZ STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1