BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ION NITRIDED BLADE

    MDR report key: 7251863 · Received February 8, 2018

    Report

    Report Number
    0001811755-2018-00394
    Event Type
    Malfunction
    Date Received
    February 8, 2018
    Date of Event
    January 11, 2018
    Report Date
    April 4, 2018
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    LGH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS AVAILABLE FOR RETURN. A FOLLOW UP REPORT WILL BE FILED ONCE THE QUALITY INVESTIGATION IS COMPLETE. AWAITING RETURN OF DEVICE TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    CATALOG NUMBER IDENTIFIED AS 0940023000. THE CAST CUTTER BLADE INVOLVED WITH THIS EVENT WAS RETURNED FOR EVALUATION. INVESTIGATION RESULTS FOR THE BLADE INDICATE THAT THERE WERE NO UNUSUAL MARKINGS ON THE RETURNED BLADE WHICH COULD HAVE CONTRIBUTED TO THE EVENT. THE IFU FOR CAST CUTTER BLADES (0840-004-700 REV H ) HAS THE FOLLOWING WARNING; ¿CUT WITH AN UP AND DOWN MOTION. STRAIGHT CUTTING MAY CUT OR BURN THE PATIENT.¿ THE DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A REMOVAL OF A CAST, THE CAST CUTTER CUT THE SKIN. NO FURTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A REMOVAL OF A CAST, THE CAST CUTTER CUT THE SKIN. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98229 ION NITRIDED BLADE INSTRUMENT, CAST REMOVAL, AC-POWERED LGH STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1