BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIS QUAD-SPARING INTRAMEDULLARY GUIDE

    MDR report key: 1812405 · Received August 17, 2010

    Report

    Report Number
    1822565-2010-00595
    Event Type
    Malfunction
    Date Received
    August 17, 2010
    Date of Event
    June 28, 2010
    Report Date
    June 28, 2010
    Manufacturer
    ZIMMER, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT UPON REMOVAL OF THE IM GUIDE WITH A SLAPHAMMER, THE DISTAL END OF THE IM GUIDE BROKE OFF AND WAS LEFT IN THE PATIENT'S FEMUR. THE ROD WAS REMOVED BY USING A PAIR OF PLIERS WHICH HAD A SLAPHAMMER ATTACHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MIS QUAD-SPARING INTRAMEDULLARY GUIDE KNEE INSTRUMENT LXH ZIMMER, INC. 60236695

    Patients

    Seq Age Sex Outcome Treatment
    1