BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRI TS BASEPLATE SIZE 4

    MDR report key: 4210957 · Received October 29, 2014

    Report

    Report Number
    0002249697-2014-04050
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Date of Event
    October 3, 2014
    Report Date
    October 3, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K053514
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE INVESTIGATION RESULTS WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    REVIEW OF THE DEVICE HISTORY RECORDS INDICATES DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER EVENTS FOR THE LOT REFERENCED. VISUAL INSPECTION: THE PRODUCT BOX IN TORN SHRINK WRAP, IMPLANT STICKERS, OPENED OUTER BLISTER AND LID, OPENED INNER BLISTER AND LID, AND INNER BLISTER CONTENTS WERE RETURNED. CONCLUSION: THE EVENT WAS CONFIRMED. VISUAL INSPECTION OF THE RETURNED INDICATED THE TOP FOAM WAS STUCK TO THE INNER TYVEK LID. THIS CAUSED THE REPORTED YELLOW STAIN ON THE INNER LID. THE ROOT CAUSE WAS DETERMINED TO BE A KNOWN PACKAGING ISSUE. PACKAGING INNOVATIONS IS AWARE OF THIS, AND HAS ISSUED A MEMO.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BASEPLATE WAS OPENED, NURSE NOTICED YELLOW COLORING ON INSIDE BOX. UPON FURTHER OPENING, THE FOAM WAS STUCK TO THE TOP LAYER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BASEPLATE WAS OPENED, NURSE NOTICED YELLOW COLORING ON INSIDE BOX. UPON FURTHER OPENING, THE FOAM WAS STUCK TO THE TOP LAYER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691385 TRI TS BASEPLATE SIZE 4 IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH KGBWD

    Patients

    Seq Age Sex Outcome Treatment
    1 Other