BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ION NITRIDED BLADE

    MDR report key: 1883115 · Received October 18, 2010

    Report

    Report Number
    9616696-2010-00305
    Event Type
    Malfunction
    Date Received
    October 18, 2010
    Date of Event
    September 22, 2010
    Report Date
    September 22, 2010
    Manufacturer
    STRYKER IRELAND LTD.
    Product Code
    GFA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAST CUTTER BLADE SUBJECT TO THIS MDR WAS RETURNED TO MANUFACTURER FOR EVALUATION. IT WAS VISUALLY CONFIRMED THAT THE BLADE WAS CRACKED ON BOTH SIDES OF THE BLADE MOUNT. THE MANUFACTURING RECORDS WERE REVIEWED, NO ISSUES WERE HIGHLIGHTED WHICH MAY HAVE CONTRIBUTED TO THIS EVENT. THE IFU HAS A WARNING WHICH STATES "EXCESSIVE PRESSURE, SUCH AS BENDING AND PRYING WITH THE BLADE, MAY CAUSE THE BLADE TO FRACTURE". THE ROOT CAUSE IS UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A REMOVAL OF A CAST ON THE WRIST, THE CAST CUTTER BLADE FELL OFF THE CAST CUTTER. IT WAS ALSO REPORTED THAT THERE WAS A CRACK IN THE BLADE. IT WAS FURTHER REPORTED THAT THERE WAS NO INJURY TO THE PATIENT AND THERE WAS ANOTHER BLADE READILY AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ION NITRIDED BLADE SAW BLADES & ACCESSORIES GFA STRYKER IRELAND LTD. 10155017

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK