BEUDAMED
    FDA Adverse Event Other Summary report: N

    SAW BLADE LINVATEC POWERPRO 90/13/1.27MM

    MDR report key: 729715 · Received June 26, 2006

    Report

    Report Number
    2916714-2006-00046
    Event Type
    Other
    Date Received
    June 26, 2006
    Report Date
    June 23, 2006
    Manufacturer
    AESCULAP, INC.
    Product Code
    ---
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ITEM WAS DISCARDED AND THEREFORE WILL NOT BE RETURNED. ALL OF THE AVAILABLE INFO HAS BEEN FORWARDED FOR ANALYSIS TO THE MFR, AESCULAP, GERMANY. NOTE: IT WAS NOTED THAT THE BLADE HIT THE CUTTING GUIDE. PLEASE SEE ATTACHED INSTRUCTIONS FOR USE #TA010224: CAUTION: INSERTING A SAW CUTTING GUIDE WHEN THE SAW IS ACTIVATED CAN CAUSE SEVERE DAMAGE TO THE SAW BLADE AND CUTTING GUIDE AND INJURY TO THE OPERATING SURGEON AND/OR PT.THEREFORE, WHEN USING A CUTTING GUIDE, INSERT THE SAW BLADE INTO THE TEMPLATE PRIOR TO OPERATING THE SAW.

    Description of Event or Problem · 1

    SURGEON PERFORMED 3 TOTAL KNEE REPLACEMENTS WHERE HE HAD TEETH FROM THE BLADE BREAK OFF INTO THE PT. AFTER HITTING THE SIDE OF THE CUTTING BLOCK-A TOOTH OR TEETH GOT KNOCKED OFF. A PORTION OF THE BLADE WAS LEFT IN THE PT'S BODY. THE BLADES WERE DISCARDED. ATTEMPTS WERE MADE TO OBTAIN FURTHER INFO, BUT IT WAS NOT AVAILABLE. REFERENCE: 2916714-2006-00047, 2916714-2006-00048.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAW BLADE LINVATEC POWERPRO 90/13/1.27MM BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL --- AESCULAP, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN