ERISMA-LP

Additional Manufacturer Narrative

DURING THE PROCEDURE, THE TIP OF THE ERISMA-LP SCREWDRIVER SHAFT #18911039 BROKE INTRAOPERATIVELY. THE FRAGMENT WAS COMPLETELY SUNK IN THE SCREW HEAD, SO IT WAS DECIDED TO LEAVE IT IN PLACE. IT IS IMPORTANT TO NOTE THAT ONCE THE ROD IMPLANT IS SEATED AND LOCKED INTO THE TULIP OF THE POLYAXIAL SCREW, THE FRACTURED TIP IS PREVENTED FROM DISLODGING AS LONG AS THE ROD REMAINS FIRMLY LOCKED INTO PLACE. THE PROCEDURE WAS COMPLETED UTILIZING ANOTHER SCREWDRIVER READILY AVAILABLE IN THE SET WITH NO DELAY. SURGERY WAS COMPLETED WITH NO FURTHER COMPLICATIONS.

Description of Event or Problem

SCREWDRIVER TIP BROKE OFF INSIDE THE SCREW HEAD. SHEARED OFF COMPLETELY SO SURGEON LEFT THE SHEARED FRAGMENT IN PLACE AND LOCKED ROD DOWN OVER TOP OF IT.

Additional Manufacturer Narrative

DURING THE PROCEDURE, THE TIP OF THE ERISMA-LP SCREWDRIVER SHAFT #18911039 BROKE INTRAOPERATIVELY. THE FRAGMENT WAS COMPLETELY SUNK IN THE SCREW HEAD, SO IT WAS DECIDED TO LEAVE IT IN PLACE. IT IS IMPORTANT TO NOTE THAT ONCE THE ROD IMPLANT IS SEATED AND LOCKED INTO THE TULIP OF THE POLYAXIAL SCREW, THE FRACTURED TIP IS PREVENTED FROM DISLODGING AS LONG AS THE ROD REMAINS FIRMLY LOCKED INTO PLACE. THE PROCEDURE WAS COMPLETED UTILIZING ANOTHER SCREWDRIVER READILY AVAILABLE IN THE SET WITH NO DELAY. SURGERY WAS COMPLETED WITH NO FURTHER COMPLICATIONS. 12/20/2019 - AFTER ANALYSIS UNDER A MAGNIFYING GLASS, IT APPEARS A NET BREAK OF THE TIP OF THE SHAFT. MOREOVER, IT IS POSSIBLE TO NOTICE A STOP AT THE OPPOSITE OF THE BREAK POINT. ALL STRIATIONS ARE IN THE SAME DIRECTION. THIS BREAK IS CHARACTERISTIC OF OVER-BENDING BY THE SURGEON.

Description of Event or Problem

SCREWDRIVER TIP BROKE OFF INSIDE THE SCREW HEAD. SHEARED OFF COMPLETELY SO SURGEON LEFT THE SHEARED FRAGMENT IN PLACE AND LOCKED ROD DOWN OVER TOP OF IT.