BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUAL CUT SAGITTAL BLADE

    MDR report key: 1915418 · Received November 4, 2010

    Report

    Report Number
    9616696-2010-00324
    Event Type
    Malfunction
    Date Received
    November 4, 2010
    Date of Event
    October 6, 2010
    Report Date
    October 8, 2010
    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 MDR WAS RETURNED TO THE MFR FOR EVAL. IT WAS VISUALLY CONFIRMED THAT ONE TAB WAS BROKEN FROM THE MOUNT OF THE BLADE. THE RETURNED PART 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 MULTIFACTORIAL. THE HANDPIECE ASSOCIATED WITH THIS MDR IS AS FOLLOWS: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE ON THE KNEE THAT THE BLADE BROKE. IT WAS ALSO REPORTED THAT THE BROKEN PIECE WAS REMOVED USING A FORCEPS AND THE SURGEON HAS NO CONCERNS ABOUT ANY PIECES BEING LEFT BEHIND IN THE PATIENT. IT WAS FURTHER REPORTED ANOTHER BLADE WAS READILY AVAILABLE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK