BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STERNUM BLADE

    MDR report key: 3902009 · Received June 30, 2014

    Report

    Report Number
    0001811755-2014-02315
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    June 9, 2014
    Report Date
    June 9, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    DWH
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED FOR EVALUATION. THE QUALITY INVESTIGATION IS COMPLETE.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BLADE BROKE DURING A PROCEDURE. IT WAS FURTHER REPORTED THAT THERE WAS A 5 MINUTE DELAY AS A RESULT. AN X-RAY WAS TAKEN TO ENSURE NO PIECE WAS LEFT BEHIND. THERE WAS NO PATIENT IMPACT OR ADVERSE CONSEQUENCES REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BLADE BROKE DURING A PROCEDURE. IT WAS FURTHER REPORTED THAT THERE WAS A 5 MINUTE DELAY AS A RESULT. AN X-RAY WAS TAKEN TO ENSURE NO PIECE WAS LEFT BEHIND. THERE WAS NO PATIENT IMPACT OR ADVERSE CONSEQUENCES REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380583 STERNUM BLADE BLADE, SAW, SURGICAL, CARDIOVASCULAR DWH STRYKER INSTRUMENTS-KALAMAZOO UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other (B)(4), LOT 1201912123