ALARA ACCESS NEEDLE

Additional Manufacturer Narrative

IT IS THE OPINION OF THE MANUFACTURER, THE DEVICE MALFUNCTION WAS CAUSED BY THE SURGEON WHO WAS ADVANCING THE ALARA ACCESS NEEDLE (BY MALLETING) INTO THE PATIENT'S VERTEBRAL BODY BEYOND THE POINT WHERE THE SHEATH EXTENDED INTO BONE. THEN WITH THE SURGEON WAS ATTEMPTING TO REMOVE THE DEVICE BY MANUALLY MANIPULATING IT, AND A SNAP WAS HEARD. FURTHERING THE SURGICAL EVENT, IT WAS DETERMINED THAT PIECES OF THE SHEATH AND THE RADIOPAQUE RING REMAINED IN BODY.

Description of Event or Problem

SURGEON HAD THE NEEDLE SET AT 3 WHICH EQUATES TO HAVING 30MM OF METAL EXPOSED BELOW THE DISTAL PLASTIC OUTER COVER. SURGEON IMPACTED THE NEEDLE ASSEMBLY APPROXIMATELY 20 MM INTO THE VERTEBRAL BODY AND A SNAP NOISE WAS HEARD. THE DEVICE MALFUNCTION WAS CAUSED BY THE SURGEON WHO WAS ADVANCING THE ALARA ACCESS NEEDLE (BY MALLETING) INTO THE PATIENT'S VERTEBRAL BODY BEYOND THE POINT WHERE THE SHEATH EXTENDED INTO BONE. THEN WITH THE SURGEON WAS ATTEMPTING TO REMOVE THE DEVICE BY MANUALLY MANIPULATING IT, AND A SNAP WAS HEARD. SURGEON TOOK AN IMAGE AND NOTED THAT 5MM OF THE DISTAL END OF THE NEEDLE WAS BROKEN OFF AND STUCK IN THE PATIENT'S PEDICLE. SURGEON ATTEMPTED TO REMOVE THE BROKEN PIECES (ADJUSTABLE SHEATH MADE OF XF 1022/9008 BLACK MATERIAL) BY SUCTION. A HOOK WAS THEN USED USE TO TRY AND REMOVE THE DISTAL METAL RING OF THE NEEDLE ASSEMBLY. SURGEON WAS UNABLE TO REMOVE THE RADIOPAQUE MARKER / RING MADE OF 304 STAINLESS STEEL. A PEDICLE SCREW WAS PLACED AND SECURED ON THE SAME PATH/TRAJECTORY AS THE NEEDLE ASSEMBLY. THIS ACTION ADVANCED THE RING/NEEDLE PLASTIC COMBINATION FORWARD. THE COMBINATION SITS APPROXIMATELY 5 MM DISTAL OF THE SCREW SHANK.