BEUDAMED
    FDA Adverse Event Other Summary report: N

    MIOS TIBIAL CUTTING GUIDE LEFT MEDIAL

    MDR report key: 734453 · Received June 28, 2006

    Report

    Report Number
    2916714-2006-00040
    Event Type
    Other
    Date Received
    June 28, 2006
    Date of Event
    May 9, 2006
    Report Date
    June 26, 2006
    Manufacturer
    AESCULAP, INC.
    Product Code
    FZX
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ITEM AND ALL OF THE AVAILABLE INFORMATION HAS BEEN FORWARDED FOR ANALYSIS TO THE MANUFACTURER, AESCULAP.

    Description of Event or Problem · 1

    DURING A TOTAL KNEE REPLACEMENT, ONE OF THE PINS BROKE OFF OF THE DISTAL FEMORAL CUTTING GUIDE INTO THE FEMUR OF THE PT. THE PIN WAS UNABLE TO BE REMOVED AND THEREFORE WAS LEFT IN THE PT. THERE WAS NO PROLONGING OF SURGERY. THE PT SUFFERED NO ADVERSE AFFECTS OF THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MIOS TIBIAL CUTTING GUIDE LEFT MEDIAL GUIDE, SURGICAL, INSTRUMENT FZX AESCULAP, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN