BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAINLESS STEEL BLADE

    MDR report key: 2379520 · Received November 7, 2011

    Report

    Report Number
    9616696-2011-00216
    Event Type
    Malfunction
    Date Received
    November 7, 2011
    Date of Event
    October 7, 2011
    Report Date
    October 7, 2011
    Manufacturer
    STRYKER IRELAND LTD.
    Product Code
    LGH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAST CUTTER BLADE ASSOCIATED WITH THIS EVENT WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. IT WAS VISUALLY CONFIRMED THAT BOTH THE BLADE TEETH AND MOUNT WERE WORN. LOT NUMBER INFORMATION HAS NOT BEEN PROVIDED TO PERMIT FURTHER INVESTIGATION. THE IFU FOR THE CAST CUTTER BLADE HAS A CAUTION WHICH STATES "STRYKER DOES NOT RECOMMEND USING SST BLADES REF 0840-040-200, 0840-040-250 AND 0940-025-000 FOR CUTTING SYNTHETIC CAST MATERIAL." THE INVESTIGATION RESULTS INDICATE THAT THE USER MAY HAVE CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE REMOVING A PADDED FIBERGLASS CAST, THE PATIENT RECEIVED A CUT ON THE ARM. IT WAS ALSO REPORTED THAT A MINOR INJURY WAS SUSTAINED, A BREAK IN THE SKIN. IT WAS FURTHER REPORTED THAT THE WOUND WAS DRESSED AND NO OTHER TREATMENT WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STAINLESS STEEL BLADE LGH STRYKER IRELAND LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK