BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIGH FLOW TRAUMA TIP

    MDR report key: 1813017 · Received August 11, 2010

    Report

    Report Number
    2648666-2010-00348
    Event Type
    Malfunction
    Date Received
    August 11, 2010
    Date of Event
    July 23, 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 CANNOT BE REVIEWED, AS THE LOT NUMBER WAS NOT PROVIDED. IF ADDITIONAL INFO IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

    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. THE ACCOUNT HAD A BACK UP ON HAND TO COMPLETE THE PROCEDURE WITH NO DELAY. THERE IS NO ALLEGATION 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK