ERISMA-LP

Additional Manufacturer Narrative

VISUAL EXAMINATION AT THE MACROSCOPIC LEVEL REVEALED THAT THE FRACTURE WAS LOCATED AT THE DISTAL TIP OF THE SCREWDRIVER SHAFT. THE FRACTURED TIP WAS NOT PROVIDED FOR ANALYSIS. THE FRACTURE ANALYSIS REPORT SUGGESTS THAT THE DRIVER UNDERWENT A BENDING OVERLOAD ON THE HEX LOBES OF THE SHAFT, ARISING FROM AN IMPROPER HANDLING OF THE INSTRUMENT. A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN CONDUCTED. NO ISSUE HAS BEEN IDENTIFIED DURING THE MANUFACTURING AND THE RELEASE OF THIS PRODUCT THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. ADDITIONALLY, NO SYSTEMATIC TREND OF SUCH OCCURRENCE HAS BEEN OBSERVED. THEREFORE, NO IMMEDIATE ACTION IS REQUIRED.

Description of Event or Problem

THE DISTAL TIP OF SCREWDRIVER BROKE OFF WHILE INSERTING A POLYAXIAL PEDICLE SCREW. THE BROKEN TIP HAS NOT BEEN RETRIEVED. IT IS CAPTURED IN THE SCREW HEAD INSIDE OF THE PATIENT WITHOUT ANY POSSIBILITY OF MIGRATION. SURGERY WAS COMPLETED WITH NO FURTHER COMPLICATIONS.