BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2108 SERIES SAGITTAL BLADE (20.7 X 0.88 X 85.0MM)

    MDR report key: 8208210 · Received January 2, 2019

    Report

    Report Number
    0001811755-2019-00001
    Event Type
    Malfunction
    Date Received
    January 2, 2019
    Date of Event
    December 10, 2018
    Report Date
    February 19, 2019
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    GFA
    UDI-DI
    04546540042026
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE FILED ONCE THE QUALITY INVESTIGATION IS COMPLETE. AWAITING DEVICE RETURN TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS INDICATE THAT THE MARKINGS ON THE BLADE SUGGEST THAT AT SOME POINT DURING THE PROCEDURE THE BLADE WAS MISLOADED. OPERATING THE BLADE WHILE IT IS MISLOADED CAUSES EXCESSIVE FORCE ON THE BLADE MOUNTS WHICH CAN CAUSE CRACKS TO FORM AND LEAD TO FAILURE AT THE BLADE MOUNT. THE BEND IN THE BLADE IS MOST LIKELY DUE TO EXCESSIVE FORCE IN THE PERPENDICULAR DIRECTION TO THE LONGITUDINAL AXIS OF THE BLADE. THE QUALITY INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ORTHOPAEDIC PROCEDURE, THE BLADE BROKE AT THE MOUNT. IT WAS ALSO REPORTED THAT THERE WAS A FIVE MINUTE DELAY AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ORTHOPAEDIC PROCEDURE, THE BLADE BROKE AT THE MOUNT. IT WAS ALSO REPORTED THAT THERE WAS A FIVE MINUTE DELAY AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2778 2108 SERIES SAGITTAL BLADE (20.7 X 0.88 X 85.0MM) BLADE, SAW, GENERAL & PLASTIC SURGERY,SURGICAL GFA STRYKER INSTRUMENTS-KALAMAZOO 18218017 04546540042026

    Patients

    Seq Age Sex Outcome Treatment
    1