BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSFX EXTERNAL FIXATION SELF DRILLING PIN

    MDR report key: 1841937 · Received August 31, 2010

    Report

    Report Number
    1822565-2010-00628
    Event Type
    Malfunction
    Date Received
    August 31, 2010
    Date of Event
    July 15, 2010
    Report Date
    August 2, 2010
    Manufacturer
    ZIMMER INC
    Product Code
    HTY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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 THE FAILURE OF THE DEVICES TO FUNCTION PROPERLY CAUSED THE SURGEON TO DEVIATE FROM THE SURGICAL TECHNIQUE BY DRILLING WITHOUT GUIDES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRANSFX EXTERNAL FIXATION SELF DRILLING PIN TRAUMA IMPLANT HTY ZIMMER INC 61156786

    Patients

    Seq Age Sex Outcome Treatment
    1 TRANSFX EXTERNAL FIXATION SELF DRILLING PIN| TRANSFX EXTERNAL FIXATION MULTI-PIN DRILL GUIDE| CATALOG #00445403008| TROCAR| LOT #UNK| CATALOG #00445004300| TRANSFX EXTERNAL FIXATION DRILL SLEEVE SET WITH| LOT # 60809850| CATALOG #00445004100| LOT #61125252