BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUAL CUT SAGITTAL BLADE

    MDR report key: 2052001 · Received February 28, 2011

    Report

    Report Number
    9616696-2011-00028
    Event Type
    Malfunction
    Date Received
    February 28, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 1, 2011
    Manufacturer
    STRYKER IRELAND LTD.
    Product Code
    HWE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE BLADE SUBJECT TO THIS EVENT WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. IT WAS VISUALLY CONFIRMED THAT ONE TOOTH WAS BROKEN ON THE CUTTING END OF THE BLADE. THE RETURNED BLADE WAS MEASURED WHERE POSSIBLE AND ALL DIMENSIONAL SPECIFICATIONS WERE MET. LOT NUMBER INFORMATION HAS NOT BEEN PROVIDED TO PERMIT FURTHER INVESTIGATION. THE ROOT CAUSE IS UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A KNEE REPLACEMENT SURGERY, THE BLADE BROKE. IT WAS FURTHER REPORTED THAT THE SURGERY WAS PROLONGED BY TEN MINUTES DUE TO RINSING OUT THE BROKEN PART. IT WAS ALSO REPORTED THAT THE SURGERY WAS FINISHED AS INTENDED USING AN ALTERNATIVE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUAL CUT SAGITTAL BLADE SAW BLADES & ACCESSORIES HWE STRYKER IRELAND LTD. 10308017

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK