BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIDENT ACET WINDOW TRIAL 54MM

    MDR report key: 2843646 · Received October 25, 2012

    Report

    Report Number
    2249697-2012-02080
    Event Type
    Malfunction
    Date Received
    October 25, 2012
    Date of Event
    October 1, 2012
    Report Date
    October 2, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    OUR SALES REP, (B)(6), ATTENDED A HIP SURGERY WITH DR. (B)(6) APPARENTLY DURING SURGERY THE TRIAL THREAD STRIPPED AND BROKE OFF. THE SURGEON REMOVED THE THREAD AND DEBRIS FROM THE WOUND. THIS CAUSED A DELAY OF 15 MINS. ACCORDING TO THE SURGEON THERE'S NO COMPLICATIONS DUE TO THE DELAY. THE ITEM WILL BE RETURNED FOR FURTHER INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIDENT ACET WINDOW TRIAL 54MM INSTRUMENT LXH STRYKER ORTHOPAEDICS MAHWAH NA SS114399

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other