BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLEX P - US FULL DOSE 10-PK

    MDR report key: 3173402 · Received June 17, 2013

    Report

    Report Number
    0002249697-2013-01928
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    June 11, 2013
    Report Date
    June 11, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LOD
    PMA / PMN Number
    K062553
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING PACKAGING DAMAGE INVOLVING A SIMPLEX PACKAGING WAS REPORTED. THE EVENT WAS NOT CONFIRMED AS THE REPORTED PRODUCT OR PHOTOGRAPHS WERE NOT PROVIDED. REVIEW OF THE BATCH MANUFACTURING RECORD INDICATES THAT THIS BATCH WAS MANUFACTURED AND SHIPPED TO STOCK WITH NO REPORTED DISCREPANCIES. REVIEW COMPLAINT HISTORY REVIEW DETERMINED THAT THERE WAS NO OTHER SIMILAR REPORTED EVENTS FOR THE LOT. THE ROOT CAUSE OF THE REPORTED LEAKING PACKAGE CANNOT BE DETERMINED AS THE PRODUCT WAS NOT RETURNED AND PHOTOGRAPHS WERE NOT PROVIDED. IT CANNOT BE DETERMINED WHEN THE DAMAGE MIGHT HAVE OCCURRED BUT BASED ON THE DESCRIPTION OF THE LEAKING PACKAGE, THE DAMAGE MOST LIKELY OCCURRED DURING TRANSIT TO THE HOSPITAL. NCR (B)(4) WAS RAISED IN JANUARY 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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FEDERAL EXPRESS DELIVERED THE CEMENT TO HOSPITAL RECEIVING AND IT WAS LEAKING SO CUSTOMER REFUSED BOXES AND IT IS RETURNED TO SHIPPER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT (B)(6) DELIVERED THE CEMENT TO HOSPITAL RECEIVING AND IT WAS LEAKING SO CUSTOMER REFUSED BOXES AND IT IS RETURNED TO SHIPPER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274082 SIMPLEX P - US FULL DOSE 10-PK IMPLANT LOD STRYKER ORTHOPAEDICS-MAHWAH RBU035

    Patients

    Seq Age Sex Outcome Treatment
    1 Other