BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIGH FLOW TRAUMA TIP

    MDR report key: 1813016 · Received August 11, 2010

    Report

    Report Number
    2648666-2010-00349
    Event Type
    Malfunction
    Date Received
    August 11, 2010
    Date of Event
    July 30, 2010
    Report Date
    August 2, 2010
    Manufacturer
    STRYKER INSTRUMENTS PUERTO RICO
    Product Code
    FQH
    PMA / PMN Number
    K972069
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS DISCARDED AT THE ACCOUNT. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO RELATED NON-CONFORMANCES OR DEVIATION REPORTS WERE FOUND THAT COULD CONTRIBUTE TO THE FAILURE ADDRESSED IN THIS COMPLAINT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TOTAL HIP ARTHROPLASTY, THE TIP OF THE DEVICE BROKE AT THE BASE. NOTHING FELL INTO THE SURGICAL SITE, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A BACK UP DEVICE. THERE ARE NO ALLEGATIONS OF ADVERSE CONSEQUENCES ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HIGH FLOW TRAUMA TIP JET LAVAGE FQH STRYKER INSTRUMENTS PUERTO RICO 10113012

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK