BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLEX P SPEEDSET FULL DOSE 1 PACK

    MDR report key: 3764030 · Received April 22, 2014

    Report

    Report Number
    0002249697-2014-01459
    Event Type
    Malfunction
    Date Received
    April 22, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 1, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MBB
    PMA / PMN Number
    K063857
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING PACKAGING DAMAGE INVOLVING 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 EXACT ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. FURTHER INFORMATION SUCH AS PHOTOGRAPHS OF THE REPORTED DAMAGE AND WHETHER THERE WAS AN ODOUR DETECTED ARE NEEDED TO COMPLETE THE INVESTIGATION FOR DETERMINING A ROOT CAUSE. HOWEVER, BASED ON THE INFORMATION PROVIDED, IT APPEARS THAT THIS PRODUCT WAS DAMAGED DUE TO INAPPROPRIATE HANDLING OR STORAGE DURING DISTRIBUTION/TRANSPORTATION. NCR (B)(4) WAS RAISED IN (B)(6) 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.

    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 THAT UPON OPENING THESE (2) DOSES THE MONOMER BOTTLES WERE CRACKED AND THE LIQUID HAD LEAKED/EVAPORATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UPON OPENING THESE (2) DOSES THE MONOMER BOTTLES WERE CRACKED AND THE LIQUID HAD LEAKED/EVAPORATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243117 SIMPLEX P SPEEDSET FULL DOSE 1 PACK IMPLANT MBB STRYKER ORTHOPAEDICS-MAHWAH DKU032

    Patients

    Seq Age Sex Outcome Treatment
    1 Other