BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FEMORAL CANAL TIP

    MDR report key: 1181857 · Received September 24, 2008

    Report

    Report Number
    2648666-2008-00111
    Event Type
    Malfunction
    Date Received
    September 24, 2008
    Date of Event
    August 26, 2008
    Report Date
    August 28, 2008
    Manufacturer
    STRYKER INSTRUMENTS PUERTO RICO
    Product Code
    FQH
    PMA / PMN Number
    K972069
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER. AN INVESTIGATION IS ANTICIPATED USING A REVIEW OF BATCH RECORDS AND PRODUCT FROM THE SAME LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE LAVAGING DURING A TOTAL HIP REPLACEMENT, THE DISTAL TIP OF THE FEMORAL CANAL TIP FOR IRRIGATION BROKE OFF IN PATIENT'S FEMUR. THE PIECE WAS ABLE TO BE RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FEMORAL CANAL TIP LAVAGE, JET FQH STRYKER INSTRUMENTS PUERTO RICO 08052012

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK