BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPLEX SYSTEM WITH VERTAPLEX HV W/O NEEDLES

    MDR report key: 3142918 · Received June 3, 2013

    Report

    Report Number
    0001811755-2013-01282
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    May 7, 2013
    Report Date
    May 7, 2013
    Manufacturer
    STRYKER INSTRUMENTS-PUERTO RICO
    Product Code
    JDZ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE FILED AFTER THE DEVICE IS RECEIVED AND THE QUALITY INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    UPON EVALUATION OF THE RETURNED UNIT, THE CLAIMED CONDITION WAS CONFIRMED. THE CEMENT MIXTURE LEAKED BETWEEN THE LID AND MIXING CHAMBER, SINCE THE CHAMBER WAS SIGNIFICANTLY CRACKED/BROKEN. THE POTENTIAL ROOT CAUSES FOR A CRACKED/BROKEN MIXING CHAMBER CAN BE ASSOCIATED BUT NOT LIMITED TO: IMPROPER DESIGN - CAN'T HANDLE TRANSFER PRESSURE. IMPROPER MATERIAL SELECTION- EMBRITTLES DUE TO STERILIZATION. IMPROPER MATERIAL SELECTION - EMBRITTLES DUE TO INCOMPATIBILITY WITH BONE CEMENT. IMPROPER FIT WITH PISTON.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE AUTOPLEX SYSTEM WAS BEING USED IN A PROCEDURE WHEN THE MACHINE CRACKED AND CEMENT WAS OBSERVED TO LEAK OUT OF IT. A BACK-UP KIT WAS OPENED TO COMPLETE THE PROCEDURE WITH NO PATIENT OR USER INJURIES, AND NO ADVERSE CONSEQUENCES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE AUTOPLEX SYSTEM WAS BEING USED IN A PROCEDURE WHEN THE MACHINE CRACKED AND CEMENT WAS OBSERVED TO LEAK OUT OF IT. A BACK-UP KIT WAS OPENED TO COMPLETE THE PROCEDURE WITH NO PATIENT OR USER INJURIES, AND NO ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243298 AUTOPLEX SYSTEM WITH VERTAPLEX HV W/O NEEDLES MIXER, CEMENT, FOR CLINICAL USE JDZ STRYKER INSTRUMENTS-PUERTO RICO UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1