BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUAL CUT SAGITTAL BLADE

    MDR report key: 3902038 · Received June 30, 2014

    Report

    Report Number
    0001811755-2014-02310
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    June 3, 2014
    Report Date
    June 11, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    GFA
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS AVAILABLE FOR RETURN. A FOLLOW UP REPORT WILL BE FILED ONCE THE QUALITY INVESTIGATION IS COMPLETE. DEVICE NOT YET RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED. THE QUALITY INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER USING THE BLADE DURING A PROCEDURE, A PIECE OF METAL WAS NOTICED TO BE LYING NEXT TO THE PATIENT. IT WAS FURTHER REPORTED THAT X-RAYS WERE TAKEN TO ENSURE NO PIECES WERE LEFT IN THE PATIENT. THERE WAS NO ADVERSE CONSEQUENCES OR SURGICAL DELAY REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER USING THE BLADE DURING A PROCEDURE A PIECE OF METAL WAS NOTICED TO BE LYING NEXT TO THE PATIENT. IT WAS FURTHER REPORTED THAT X-RAYS WERE TAKEN TO ENSURE NO PIECES WERE LEFT IN THE PATIENT. THERE WAS NO ADVERSE CONSEQUENCES OR SURGICAL DELAY REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380094 DUAL CUT SAGITTAL BLADE BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL GFA STRYKER INSTRUMENTS-KALAMAZOO UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other UNKNOWN INS HANDPIECE, UNKNOWN INS LOT #