BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRI TS BASEPLATE SIZE 4

    MDR report key: 3213397 · Received July 9, 2013

    Report

    Report Number
    0002249697-2013-02228
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    June 26, 2013
    Report Date
    June 26, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K053514
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    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 INNER BLISTER LID DAMAGE INVOLVING A TRI TS BASEPLATE SIZE 4 WAS REPORTED. THE EVENT WAS CONFIRMED. VISUAL ANALYSIS CONFIRMED THE EVENT. THE INNER BLISTER LID HAD TWO AREAS OF YELLOWING WHERE THE BLISTER WAS WRINKLED. THE SEAL OF BOTH THE OUTER AND INNER BLISTER WERE EXAMINED AND WERE UNREMARKABLE AND SHOWED SIGNS OF A COMPLETE SEAL TRANSFER. DEVICE HISTORY REVIEW INDICATED ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW INDICATED THERE HAVE BEEN NO OTHER EVENTS FOR THIS LOT. THE INVESTIGATION CONCLUDED THAT YELLOWED, WRINKLED AREA OF THE INNER BLISTER LID WAS CAUSED BY CONTACT BETWEEN THE LID AND THE FOAM UNDERNEATH DURING THE PACKAGING AND HEAT SEAL PROCESS. PACKAGING INNOVATIONS CONFIRMED THE STERILITY OF THE DEVICE IS NOT COMPROMISED IN THIS SITUATION.

    Description of Event or Problem · 1

    THE SURGEON COMPLAINED THE PACKAGE OF UNIVERSAL TIBIAL BASEPLATE TO LOOK AS IF IT WAS WET INSIDE AND NONSTERILE BEFORE OPENING THE PACKAGE. WAS NOT USABLE IN THE SURGERY.

    Description of Event or Problem · 1

    THE SURGEON COMPLAINED THE PACKAGE OF UNIVERSAL TIBIAL BASEPLATE TO LOOK AS IF IT WAS WET INSIDE AND NONSTERILE BEFORE OPENING THE PACKAGE. WAS NOT USABLE IN THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313614 TRI TS BASEPLATE SIZE 4 IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH AYRZ

    Patients

    Seq Age Sex Outcome Treatment
    1 Other