BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.3MM SPIRAL ROUTER

    MDR report key: 7495286 · Received May 8, 2018

    Report

    Report Number
    0001811755-2018-00964
    Event Type
    Malfunction
    Date Received
    May 8, 2018
    Date of Event
    April 16, 2018
    Report Date
    June 13, 2018
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HBE
    UDI-DI
    07613327096712
    PMA / PMN Number
    K143399
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS INDICATE THAT THE MOST LIKELY CAUSE OF FAILURE IS THE ATTACHMENT LOCK NOT CORRECTLY LOADED OR LOCKED INTO THE ATTACHMENT. THE IFU FOR THE ATTACHMENT (5407-210-768 REV-B) HAS THE FOLLOWING WARNING; " WHILE ALIGNING THE DOTS ON THE ATTACHMENT AND MOTOR, SLIDE THE ATTACHMENT OVER THE CUTTING ACCESSORY AND ONTO THE MOTOR UNTIL IT SNAPS INTO PLACE. WARNING: OPERATING THE MOTOR WITHOUT THE ATTACHMENT SECURELY CONNECTED AND CUTTING ACCESSORY SECURELY LOCKED MAY RESULT IN PATIENT OR HEALTHCARE STAFF INJURY. GENTLY TUG THE ATTACHMENT TO VERIFY IT IS SECURE." THE QUALITY INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A POSTERIOR CERVICAL BILATERAL LAMINECTOMY, THE ROUTER BROKE INTO THREE PIECES. IT WAS ALSO REPORTED THAT THERE WERE NO DELAYS AND NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A POSTERIOR CERVICAL BILATERAL LAMINECTOMY, THE ROUTER BROKE INTO THREE PIECES. IT WAS ALSO REPORTED THAT THERE WERE NO DELAYS AND NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338119 2.3MM SPIRAL ROUTER DRILLS, BURRS, TREPHINES & ACCESSORIES HBE STRYKER INSTRUMENTS-KALAMAZOO 5407FA2023SP 16147037 07613327096712

    Patients

    Seq Age Sex Outcome Treatment
    1