BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGICAL SIMPLEX CEMENT

    MDR report key: 2933734 · Received January 29, 2013

    Report

    Report Number
    0002249697-2013-00439
    Event Type
    Malfunction
    Date Received
    January 29, 2013
    Date of Event
    January 8, 2013
    Report Date
    January 9, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LOD
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THAT THE REPORTED DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THE COMPLAINT HISTORY REVIEW INDICATED THAT THERE WERE NO SIMILAR EVENTS FOR THE REPORTED LOT. THE EVENT WAS CONFIRMED. VISUAL INSPECTION NOTED THAT THE INNER POUCH HAD BEEN STUCK IN THE OUTER POUCH. THE INNER POUCH SEAL GOT TRAPPED IN THE OUTER POUCH SEAL DURING MANUFACTURING. THE INNER POUCH SEAL WAS FULLY INTACT. THE OUTER POUCH HAD A FULL SEAL ACROSS THE ENTIRE POUCH WIDTH WITH THE INNER POUCH ENCROACHING INTO THE OUTER POUCH SEAL. THE INNER AND OUTER POUCH COMBINATION ARE STERILISED AS ONE UNIT. BOTH SEALS WERE INTACT THEREFORE THERE IS NO CONCERN OVER THE STERILITY OF THE POWDER. DEVICE DEFECT AWARENESS (DDA) TRAINING WITH ALL OPERATORS INVOLVED IN THE MANUFACTURING AND INSPECTION OF SIMPLEX PRODUCT WAS COMPLETED. THE TRAINING INCLUDED REVIEW OF THE NATURE AND CONSEQUENCE OF THE ISSUE AND A REVIEW OF THE RETURNED DEVICE.

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. THE SUBJECT DEVICE IS NOT CLEARED FOR SALE IN THE U.S., BUT A SIMILAR DEVICE IS COMMERCIALLY AVAILABLE IN THE U.S.

    Description of Event or Problem · 1

    DURING SURGERY, IT WAS HARD TO REMOVE THE INNER POUCH DUE TO INGRESS OF INNER POUCH INTO OUTER SEAL. A BACKUP DEVICE WAS USED.

    Description of Event or Problem · 1

    DURING SURGERY, IT WAS HARD TO REMOVE THE INNER POUCH DUE TO INGRESS OF INNER POUCH INTO OUTER SEAL. A BACKUP DEVICE WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39596 SURGICAL SIMPLEX CEMENT IMPLANT LOD STRYKER ORTHOPAEDICS-MAHWAH JJT035

    Patients

    Seq Age Sex Outcome Treatment
    1 Other