BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLEX P WITH TOBRAMYCIN 1 PACK

    MDR report key: 3924346 · Received July 9, 2014

    Report

    Report Number
    0002249697-2014-02592
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    June 12, 2014
    Report Date
    June 12, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LOD
    PMA / PMN Number
    K014199
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING PACKAGING DAMAGE INVOLVING A SIMPLEX PACKAGING WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVICE HISTORY REVIEW OF THE BATCH MANUFACTURING RECORD INDICATES THAT THIS BATCH WAS MANUFACTURED AND SHIPPED TO STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW DETERMINED THAT THERE WERE NO OTHER SIMILAR REPORTED EVENTS FOR THE LOT. THE EVENT WAS NOT CONFIRMED AS THE REPORTED PRODUCT OR PHOTOGRAPHS WERE NOT PROVIDED FOR REVIEW. BASED ON THE INFORMATION PROVIDED BY THE CUSTOMER, THERE WAS AN ODOUR COMING FROM THE PRODUCT WHEN THE REPORTED DAMAGE WAS NOTED. THIS INDICATES THAT AN AMPOULE(S) WAS BROKEN AT THE TIME OR SHORTLY BEFORE THE PRODUCT WAS RECEIVED BY THE CUSTOMER AS THE SMELL WOULD HAVE COME FROM THE MONOMER WHEN THE AMPOULE WAS BROKEN. THIS ODOUR FROM THE MONOMER LIQUID LASTS A SHORT PERIOD OF TIME AS THE LIQUID EVAPORATES WHEN EXPOSED TO THE ATMOSPHERE. BASED ON THE DESCRIPTION OF THE EVENT AND THE ADDITIONAL INFORMATION PERTAINING TO THE DETAILS OF THE PACKAGING AND DAMAGE NOTED, IT APPEARS THAT THIS PRODUCT WAS DAMAGED DUE TO INAPPROPRIATE HANDLING OR STORAGE DURING DISTRIBUTION/TRANSPORTATION. (B)(4) WAS RAISED IN (B)(4) 2010 TO ADDRESS A TREND NOTED FOR DAMAGE TO SIMPLEX PACKAGING. THIS TREND WAS BASED ON THE VOLUME OF COMPLAINTS RECEIVED ASSOCIATED WITH PACKAGING DAMAGE FOR SIMPLEX PRODUCT. UPON APPLICATION OF ADVERSE TREND DETECTION IT WAS DETERMINED THAT THE RATE IS WITHIN THE RISK ACCEPTABILITY CRITERIA. PACKAGE DESIGN REVIEW WAS CARRIED OUT AS PART OF THE NCR AND IT WAS DETERMINED THAT FURTHER DESIGN REVIEW WILL BE COMPLETED UNDER PACKAGING INNOVATION QUALITY IMPROVEMENT PROJECTS. NO FURTHER INVESTIGATION IS POSSIBLE AT THIS TIME AS NO PRODUCT AND INSUFFICIENT INFORMATION WAS RECEIVED BY STRYKER ORTHOPAEDICS.

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION WAS REQUESTED AND IF IT BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. NOT RETURNED

    Description of Event or Problem · 1

    IT WAS REPORTED BY (B)(6) HOSPITAL THAT ONE DOSE, 6197-9-001, WAS BROKEN AND LEAKING FROM SHIP. THERE WAS ALSO A STRONG ODOR.

    Description of Event or Problem · 1

    IT WAS REPORTED BY (B)(6) ORTHOPEDIC SURGICAL HOSPITAL THAT ONE DOSE, (B)(4), WAS BROKEN AND LEAKING FROM SHIP. THERE WAS ALSO A STRONG ODOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401834 SIMPLEX P WITH TOBRAMYCIN 1 PACK IMPLANT LOD STRYKER ORTHOPAEDICS-MAHWAH MAV008

    Patients

    Seq Age Sex Outcome Treatment
    1