BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLEX P-JAPANESE TWIN PACK

    MDR report key: 2950974 · Received February 8, 2013

    Report

    Report Number
    0002249697-2013-00593
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Date of Event
    January 25, 2013
    Report Date
    January 25, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LOD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT 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.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING GLASS BREAKING OFF A SIMPLEX LIQUID AMPOULE WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVICE EVALUATION NOT PERFORMED AS NO ITEMS WERE RETURNED AS THE DEVICES WERE DISCARDED. DEVICE HISTORY REVIEW NOT PERFORMED AS NO LOT ID WAS PROVIDED. COMPLAINT HISTORY REVIEW NOT PERFORMED AS NO LOT ID WAS PROVIDED. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED AS THE AMPOULE WAS NOT RETURNED FOR EVALUATION, HOWEVER IT SHOULD BE NOTED THAT THE IFU REFERS TO PRECAUTIONS ABOUT THE METHOD OF USE: DO NOT OPEN THE AMPOULE OVER THE MIXING CONTAINER. PIECES OF GLASS MAY FALL INTO THE CONTAINER AND GET INTERMIXED WITH THE BONE CEMENT. BASED ON THE INFORMATION PROVIDED, IT APPEARS THAT THE CUSTOMER IN THIS CASE DID NOT FOLLOW THIS INSTRUCTION AS THE TIP OF THE AMPOULE FELL INTO THE MIXER. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS THE AMPOULE IN QUESTION WAS DISCARDED BY THE CUSTOMER, THEREFORE AN EVALUATION COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE GLASS AMPOULE TIP SHATTERED WHEN THE USER APPLIED A FORCE TO OPEN THE AMPOULE. THE TIP FELL INTO THE SYRINGE OF THE REVOLUTION, BUT IT WAS NOT INSERTED INTO THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE GLASS AMPOULE TIP SHATTERED WHEN THE USER APPLIED A FORCE TO OPEN THE AMPOULE. THE TIP FELL INTO THE SYRINGE OF THE REVOLUTION, BUT IT WAS NOT INSERTED INTO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53776 SIMPLEX P-JAPANESE TWIN PACK IMPLANT LOD STRYKER ORTHOPAEDICS-MAHWAH

    Patients

    Seq Age Sex Outcome Treatment
    1 Other