BEUDAMED
    FDA Adverse Event Death Summary report: N

    SAFEDGE SAFEDGE 2108 SAGITTAL BLADE STERNUM REVISION

    MDR report key: 18967201 · Received March 25, 2024

    Report

    Report Number
    3015967359-2024-00551
    Event Type
    Death
    Date Received
    March 25, 2024
    Date of Event
    February 27, 2024
    Report Date
    March 25, 2024
    Manufacturer
    STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP
    Product Code
    GFA
    UDI-DI
    04546540042088
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H6: THE QUALITY INVESTIGATION IS COMPLETE. H3 OTHER TEXT : DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING "OPENING OF THE STERNUM, INTRAOPERATIVELY, IT WAS REPORTED THAT THE SAW HAD FAILED, WHICH CAUSED MYOCARDIAL INJURY". FURTHER DETAILS PROVIDED STATED THAT THIS WAS AN ELECTIVE PROCEDURE FOR ATRIOVENTRICULAR SEPTUM CORRECTION. THE BLADE BEING USED WAS NOT REPORTED TO HAVE MALFUNCTIONED. IT WAS FURTHER REPORTED THAT DURING THE INCISION IN THE STERNUM, THE SAW WENT BEYOND THE BONE LIMITS AND REACHED STRUCTURES OF THE MYOCARDIAL MUSCLES. THE PATIENT DIED FOLLOWING THIS PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    500359 SAFEDGE SAFEDGE 2108 SAGITTAL BLADE STERNUM REVISION BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL GFA STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 23137017 04546540042088

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death 7208000000 SYSTEM 7 SAGITTAL SAW| 7215000000 STRYKER SMARTLIFE BATTERY PACK, LARGE