BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPLEX SYSTEM W/ VERTAPLEX W/O NEEDLES

    MDR report key: 3140406 · Received May 31, 2013

    Report

    Report Number
    0001811755-2013-01262
    Event Type
    Malfunction
    Date Received
    May 31, 2013
    Date of Event
    May 3, 2013
    Report Date
    May 3, 2013
    Manufacturer
    STRYKER INSTRUMENTS-PUERTO RICO
    Product Code
    JDZ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 INVESTIGATION FINDINGS, THE CLAIMED CONDITION WAS CONFIRMED ON BOTH UNITS. UPON EVALUATION, CEMENT LEAKAGE WAS DETECTED BETWEEN THE LUER SPINDLE AND LUER HOUSING FROM THE EXTENSION TUBE ASSEMBLY. THE O-RING (ONE OF THE TWO O-RINGS ASSEMBLED) WAS PARTIALLY SHIFTED FROM THE GROVE AND BROKEN CAUSING CEMENT LEAKAGE. ALTHOUGH A DEFINITE ROOT CAUSE COULD NOT BE CONFIRMED, THE MOST PROBABLE ROOT CAUSE CAN BE ASSOCIATED, BUT NOT LIMITED TO: EXCESSIVE INJECTION PRESSURE CAUSES FAILURE AT COMPONENT JUNCTIONS LEADING TO CEMENT LEAKAGE. O-RING IS DAMAGED/ IMPROPER MATERIAL/IMPROPER DESIGN/ INSUFFICIENT O-RING COMPRESSION THE O-RING WAS PLACED INTO GROOVE INCORRECTLY. POOR SEAL BETWEEN LUER HOUSING AND LUER SPINDLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE AUTOPLEX SYSTEM WAS BEING USED IN A PROCEDURE WHEN THE CEMENT WAS OBSERVED TO LEAK. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, 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 CEMENT WAS OBSERVED TO LEAK. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, WITH NO PATIENT OR USER INJURIES, AND NO ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241645 AUTOPLEX SYSTEM W/ VERTAPLEX W/O NEEDLES MIXER, CEMENT, FOR CLINICAL USE JDZ STRYKER INSTRUMENTS-PUERTO RICO 13080012

    Patients

    Seq Age Sex Outcome Treatment
    1