BEUDAMED
    FDA Adverse Event Other Summary report: N

    F.A.S.T. PEG DRIVER 2.0MM

    MDR report key: 698369 · Received April 11, 2006

    Report

    Report Number
    3003506715-2006-00007
    Event Type
    Other
    Date Received
    April 11, 2006
    Date of Event
    March 9, 2006
    Report Date
    April 10, 2006
    Manufacturer
    HAND INNOVATIONS, LLC.
    Product Code
    HTW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE TIP OF AN FDP 20 (TM) (F.A.S.T PEG DRIVER 2.0 MM (TM) STRIPPED WHILE THE SURGEON ATTEMPTED TO EXTRACT A WRIST FIXATION IMPLANT. THERE WAS NO REPLACEMENT (FPD 20 (TM) AVAILABE IN THE SET THUS PREVENTING THE SURGEON FROM SUCCESSFULLY EXTRACTING THE IMPLANT. THE FAILURE TO HAVE A REPLACEMENT FPD 20 (TM) AVAILABLE IN THE SET THUS PREVENTING THE SURGEON FROM SUCCESSFULLY EXTRACTING THE IMPLANT. THE FAILURE TO HAVE A REPLACEMENT FDP 20 (TM) IN THE SET RESULTED IN SURGICCAL DEPLAY AND CAUSED AN ADVERSE IMPACT TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 F.A.S.T. PEG DRIVER 2.0MM PEG DRIVER HTW HAND INNOVATIONS, LLC. * NI

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other