BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRYKER INSTRUMENT DIV.

    MDR report key: 1357831 · Received January 23, 2006

    Report

    Report Number
    1357831
    Event Type
    Malfunction
    Date Received
    January 23, 2006
    Date of Event
    December 27, 2005
    Report Date
    December 20, 2005
    Manufacturer
    STRYKER INSTRUMENTS
    Product Code
    FQH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WHEN USING IRRIGATOR TIP, PART OF TIP BROKE OFF INTO PATIENTS FEMORAL CANAL. O.R. TEAM WAS UNABLE TO GET THE TIP WHEN TRIED TO IRRIGATE. SECOND TIME USING ANOTHER FEMORAL CANAL TIP SAME THING HAPPENED. MD UNABLE TO GET PLASTIC PIECES OUT OF CANAL. TIPS PUSHED DISTALLY IN LEG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRYKER INSTRUMENT DIV. FEMORAL CANAL TIP FOR STRYKER/IRRIGATOR INTERPULSE FQH STRYKER INSTRUMENTS 31009010526701215

    Patients

    Seq Age Sex Outcome Treatment
    1 Other