BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEFF FEMOROTIBIAL NAIL DRILL GUIDE

    MDR report key: 636919 · Received September 22, 2005

    Report

    Report Number
    1822565-2005-00184
    Event Type
    Injury
    Date Received
    September 22, 2005
    Date of Event
    August 3, 2005
    Report Date
    August 8, 2005
    Manufacturer
    ZIMMER, INC.
    Product Code
    FZH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE DEVICE WAS USED IN SURGERY IN 2005. THE DRILL GUIDE HAD TOO MUCH SIDEWAYS TOGGLE TO BE ACCURATE WHILE DRILLING THE PROXIMAL ANTERIOR TIBIA FOR FINAL MORSE TAPER LOCK DOWN. SCREWS WERE INSERTED CROSS-THREADED AND THE NAIL SEPARATED. REVISION SURGERY WAS PERFORMED 5 DAYS LATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEFF FEMOROTIBIAL NAIL DRILL GUIDE TRAUMA INSTRUMENT FZH ZIMMER, INC. NA 34987600

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization| R