BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIDENT ACET WINDOW TRIAL 68MM

    MDR report key: 3875224 · Received June 16, 2014

    Report

    Report Number
    0002249697-2014-02299
    Event Type
    Malfunction
    Date Received
    June 16, 2014
    Date of Event
    May 26, 2014
    Report Date
    May 26, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENTS REPORTED FOR THE REPORTED MANUFACTURING LOT VISUAL, DIMENSIONAL AND FUNCTIONAL ANALYSIS COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED. PHOTOS OF SEVERAL OF THE DEVICES REPORTED IN THIS PI WERE PROVIDED WHICH SHOWED A BLACK SMUDGE ON A PIECE OF GAUZE WHICH PRESUMABLY CAME FROM THE DEVICES. THE EVENT WAS CONFIRMED BY THE PHOTOS TAKEN AT THE HOSPITAL. THE ROOT OF THE REPORTED EVENT COULD NOT BE DETERMINED DUE TO THE MINIMAL INFORMATION RECEIVED. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS NO DEVICES AND INSUFFICIENT INFORMATION WAS RECEIVED BY STRYKER ORTHOPAEDICS. IF DEVICES AND / OR ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    SOME TRIDENT WINDOW TRIALS THAT WERE BRAND NEW, DETACHED BLACK INK IN THE CASE. THIS WAS NOTICED WHEN A SURGERY WAS ABOUT TO START. THE SURGERY WAS CANCELLED DUE TO THIS ISSUE. THEY REPROCESSED THIS CASE AGAIN, AND AGAIN THEY NOTICED SOME BLACK INK POSTS.

    Description of Event or Problem · 1

    SOME TRIDENT WINDOW TRIALS THAT WERE BRAND NEW, DETACHED BLACK INK IN THE CASE. THIS WAS NOTICED WHEN A SURGERY WAS ABOUT TO START. THE SURGERY WAS CANCELLED DUE TO THIS ISSUE. THEY REPROCESSED THIS CASE AGAIN, AND AGAIN THEY NOTICED SOME BLACK INK POSTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352271 TRIDENT ACET WINDOW TRIAL 68MM INSTRUMENT LXH STRYKER ORTHOPAEDICS-MAHWAH MHL3N4

    Patients

    Seq Age Sex Outcome Treatment
    1 Other