BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENSPIRE

    MDR report key: 3899163 · Received May 21, 2014

    Report

    Report Number
    3007289746-2014-00002
    Event Type
    Injury
    Date Received
    May 21, 2014
    Date of Event
    April 30, 2014
    Report Date
    April 30, 2014
    Manufacturer
    SPINE VIEW INC.
    Product Code
    HRX
    PMA / PMN Number
    K120680
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE DOCTOR SUCCESSFULLY PERFORMED A DISCECTOMY ON THE FIRST LEVEL AND WAS ATTEMPTING TO PERFORM ANOTHER ONE ON A SECOND LEVEL WHEN HE HEARD A NOTICEABLE CHANGE IN SOUND OF THE DEVICE. THE SURGEON STOPPED THE DEVICE ASTER HEARING THE CHANGE IN SOUND AT THE SECOND LEVEL AND UPON REMOVAL NOTED THAT THE DRILL AND PART OF THE SHEATH TIP ON THE DISTAL END WERE BROKEN AND INSIDE THE PT'S DISC. ON A F/U CALL, THE SURGEON MENTIONED THAT HE HAD EXPERIENCED SOME DRAGGING DIFFICULTY DURING RE-INSERTION OF THE SAME DEVICE INTO THE CANNULA TO PERFORM A SECOND LEVEL DISCECTOMY. THE DEVICE FAILURE MODE OF THE DEVICE WAS SUCCESSFULLY REPRODUCED WHEN A LIGHT KINK OR BEND WAS APPLIED AT THE DISTAL END OF THE DEVICE CAUSING THE CUTTER TO ROTATE OFF AXIS. THIS NON CONCENTRIC ROTATION OF THE TIP CAN CAUSE THE FAILURE OF THE POLYIMIDE SHAFT JOINT, SHEATH TIP BOND JOINT OR CAUSE THE HELIX CUTTER FAILURE.

    Description of Event or Problem · 1

    DURING A CASE INVOLVING A MALE IN HIS 30'S ON CERVICAL SPINE, THE ENSPIRE CERVICAL DISCECTOMY SYSTEM HAD A NOTICEABLE CHANGE IN SOUND AS SURGEON WAS PERFORMING A DISCECTOMY ON THE SECOND LEVEL (FIRST LEVEL WENT WELL). THE SURGEON STOPPED THE DEVICE AND UPON REMOVAL NOTED THAT THE DRILL AND PART OF THE SHEATH TIP ON THE DISTAL END WERE BROKEN AND INSIDE THE PT'S DISC. THE SURGERY WAS STOPPED AND PT WAS REFERRED TO A NEUROSURGEON TO DETERMINE NEXT COURSE OF ACTION. NEUROSURGERY RECOMMENDED INTERVENTION TO REMOVE THE BROKEN PIECE AND THIS WAS DONE ON (B)(6) 2014 SUCCESSFULLY. PT WAS REPORTED AS DOING WELL AFTER THE INTERVENTION AND RECOVERING AS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303348 ENSPIRE DEBRIDER HRX SPINE VIEW INC. 20131004-01FG

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Hospitalization| R