BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAGITTAL BLADE

    MDR report key: 1160014 · Received September 12, 2008

    Report

    Report Number
    9616696-2008-00049
    Event Type
    Malfunction
    Date Received
    September 12, 2008
    Date of Event
    August 13, 2008
    Report Date
    August 13, 2008
    Manufacturer
    STRYKER IRELAND LTD.
    Product Code
    GFA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED FOR EVALUATION. THE PART NUMBER INVOLVED IN THIS INCIDENT IS UNKNOWN ALL THIS TIME. FURTHER INVESTIGATION WILL BE CARRIED OUT AND A FOLLOW UP REPORT WILL BE ISSUED IF FURTHER INFORMATION IS DISCOVERED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 2 SAGITTAL BLADES BROKE DURING A TOTAL KNEE REPLACEMENT. IT WAS FURTHER REPORTED THAT A BROKEN PIECE FELL INTO THE FEMORAL CANAL. IT WAS REPORTED THAT ALL BROKEN PIECES WERE RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAGITTAL BLADE SAW BLADES & ACCESSORIES GFA STRYKER IRELAND LTD. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK