BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STERNUM BLADE

    MDR report key: 3943781 · Received July 18, 2014

    Report

    Report Number
    0001811755-2014-02573
    Event Type
    Injury
    Date Received
    July 18, 2014
    Date of Event
    June 24, 2014
    Report Date
    June 24, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    DWH
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE QUALITY INVESTIGATION IS COMPLETE. DEVICE NOT RETURNED TO THE MANUFACTURER.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE THE SAW BLADE BROKE DURING THE CUT. WHEN THE BLADE BREAK WAS NOTICED AN X-RAY WAS TAKEN AND THE OTHER PART OF THE BLADE WAS FOUND IN THE PATIENT. IT WAS FURTHER REPORTED THAT THIS RESULTED IN A SURGICAL DELAY OF 15-20 MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE THE SAW BLADE BROKE DURING THE CUT. WHEN THE BLADE BREAK WAS NOTICED, AN X-RAY WAS TAKEN AND THE OTHER PART OF THE BLADE WAS FOUND IN THE PATIENT. IT WAS FURTHER REPORTED THAT THIS RESULTED IN A SURGICAL DELAY OF 15-20 MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422013 STERNUM BLADE BLADE, SAW, SURGICAL, CARDIOVASCULAR DWH STRYKER INSTRUMENTS-KALAMAZOO UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other