BEUDAMED
    FDA Adverse Event Other Summary report: N

    1222081-2007-00021

    MDR report key: 981405 · Received July 27, 2007

    Report

    Report Number
    1222081-2007-00021
    Event Type
    Other
    Date Received
    July 27, 2007
    Product Code
    HTT
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    THERE ARE CIRCUMFERENTIAL GALLING/SCRATCHES ON THE MID-SECTION OF THE BURR SHAFT. WHEN THE BURR IS INTRODUCED INTO THE OUTER SHEATH, IT MAKES CONTACT WITH INTERIOR OF OUTER SHEATH. THE OUTER SHEATH APPEARS TO BE SLIGHTLY BENT AT THE SAME LOCATION THAT WE SEE THE SCORINGS ON THE INNER BURR SHAFT. THIS SLIGHT BEND IN THE OUTER SHEATH MAY HAVE CAUSED CONTACT BETWEEN THE SHEATH AND THE INNER BURR SHAFT WHEN SHAFT WAS SPINNING AT HIGH SPEED RESULTING IN METAL PARTICLES. IT IS POSSIBLE THAT THE OUTER SHEATH WAS BENT DURING OR BEFORE USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HTT

    Patients

    Seq Age Sex Outcome Treatment
    1