BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCORPIO SIZE 5 CR INSERT 8MM

    MDR report key: 3130078 · Received May 24, 2013

    Report

    Report Number
    0002249697-2013-01786
    Event Type
    Malfunction
    Date Received
    May 24, 2013
    Date of Event
    May 7, 2013
    Report Date
    May 7, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K033342
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING PACKAGING DAMAGE INVOLVING A SCORPIO CR INSERT WAS REPORTED. THE EVENT WAS CONFIRMED. -DEVICE EVALUATION AND RESULTS: VISUAL INSPECTION CONFIRMED THAT THE OUTER AND INNER BLISTER WAS DEFORMED. IT APPEARS THAT THIS PACK WAS SUBJECT TO A HEAT SOURCE TO THE EXTENT THAT THE PACK BELLOWED OUT, THE OUTER FOIL LID SEAL WAS BROKEN AND THE PACK WAS DEFORMED WHEN THE PACK COOLED. THE INNER BLISTER HAS BELLOWED OUT ALSO AND THE INNER FOIL LID SEAL REMAINS INTACT. -DEVICE HISTORY REVIEW: DHR REVIEW FOR THE REPORTED LOT DETERMINED THAT THE DEVICE WAS MANUFACTURED AND PACKED TO SPECIFICATION. -COMPLAINT HISTORY REVIEW: CHR REVIEW DETERMINED THAT THERE WERE NO SIMILAR EVENTS REPORTED FOR THE LOT. CONCLUSIONS: THE PACKAGING CELL REVIEWED THE RETURNED PRODUCT AND CONCLUDED THAT THE DAMAGE NOTED WAS CAUSED WHEN THE PART WAS BEING SHRINK WRAPPED IN THE PACKAGING CELL. THE ISSUE WAS DISCUSSED AT THE TIME OF THE COMPLAINT, AND IT WAS DETERMINED THAT THIS ISSUE DOES NOT WARRANT AN NCR AS THE CORRECTIONS HAVE ALREADY BEEN IMPLEMENTED AND THERE HAVE BEEN NO OTHER COMPLAINTS NOTED FOR THIS ISSUE.

    Description of Event or Problem · 1

    THIS OCCURRED DURING A TKR AT DUBBO PRIVATE HOSPITAL. A SCORPIO CR TIBIAL INSERT WAS TO BE OPEN FOR IMPLANTATION. THE OUTER CARDBOARD BOX WAS INTACT AND UNDAMAGED AND WAS OPENED. THE PLASTIC CONTAINER WAS FOUND TO BE MISSHAPEN AND THE FOIL SEAL BROKEN. THE INNER PLASTIC CONTAINER WAS ALSO MISSHAPEN THOUGH THE FOIL SEAL APPEARED TO BE INTACT. THIS PROSTHESIS WAS NOT USED AND DID NOT ENTER THE STERILE FIELD.

    Description of Event or Problem · 1

    THIS OCCURRED DURING A TKR AT DUBBO PRIVATE HOSPITAL. A SCORPIO CR TIBIAL INSERT WAS TO BE OPEN FOR IMPLANTATION. THE OUTER CARDBOARD BOX WAS INTACT AND UNDAMAGED AND WAS OPENED. THE PLASTIC CONTAINER WAS FOUND TO BE MISSHAPEN AND THE FOIL SEAL BROKEN. THE INNER PLASTIC CONTAINER WAS ALSO MISSHAPEN THOUGH THE FOIL SEAL APPEARED TO BE INTACT. THIS PROSTHESIS WAS NOT USED AND DID NOT ENTER THE STERILE FIELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231340 SCORPIO SIZE 5 CR INSERT 8MM IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH LBV902

    Patients

    Seq Age Sex Outcome Treatment
    1 Other