BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAGITTAL BLADE 25.0X1.27X90MM

    MDR report key: 1963732 · Received December 22, 2010

    Report

    Report Number
    9616696-2010-00382
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    December 7, 2010
    Report Date
    December 7, 2010
    Manufacturer
    STRYKER IRELAND LTD.
    Product Code
    GFA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE BLADE SUBJECT TO THIS MDR WAS RETURNED TO THE MFR FOR EVAL. IT WAS VISUALLY CONFIRMED THAT THE BLADE TEETH WERE VERY WORN. THE RETURNED BLADE WAS MEASURED WHERE POSSIBLE AND ALL CRITICAL SPECIFICATIONS WERE MET. LOT NUMBER INFO 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 TOTAL KNEE ARTHROPLASTY PROCEDURE SHAVINGS FROM THE BLADE FELL INTO THE SURGICAL SITE. IT WAS ALSO REPORTED THAT THE SHAVINGS WERE REMOVED USING PULSED LAVAGE AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PT. IT WAS FURTHER REPORTED THAT ANOTHER BLADE WAS READILY AVAILABLE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAGITTAL BLADE 25.0X1.27X90MM SAW BLADES & ACCESSORIES GFA STRYKER IRELAND LTD. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK