ERISMA-LP

Description of Event or Problem

THE TIPS OF THE ERISMA DRIVERS BROKE OFF WHILE THE DR. INSERTING THE REDUCTION AND SIMULTANEOUSLY PULLING LATERALLY TO RETRACT TISSUE. THE SAME ACTION BROKE TWO DRIVERS IN THE PERIOD OF 5 MINUTES. THERE WAS NO HARM TO THE PATIENT.

Additional Manufacturer Narrative

TWO SHAFTS #1891040 OF THE REDUCTION POLYAXIAL SCREWDRIVER BROKE DURING SURGERY. THE TIPS BROKE OFF WHILE THE SURGEON WAS INSERTING THE SCREW AND SIMULTANEOUSLY PULLING LATERALLY TO RETRACT TISSUE. HOWEVER, NO PATIENT HARM WAS REPORTED, AND THE SURGERY WAS ABLE TO BE COMPLETED WITHOUT FURTHER INCIDENT. THIS EVENT IS REPORTABLE AS A MALFUNCTION.

Additional Manufacturer Narrative

TWO SHAFTS #1891040 OF THE REDUCTION POLYAXIAL SCREWDRIVER BROKE DURING SURGERY. THE TIPS BROKE OFF WHILE THE SURGEON WAS INSERTING THE SCREW AND SIMULTANEOUSLY PULLING LATERALLY TO RETRACT TISSUE. HOWEVER, NO PATIENT HARM WAS REPORTED, AND THE SURGERY WAS ABLE TO BE COMPLETED WITHOUT FURTHER INCIDENT. THIS EVENT IS REPORTABLE AS A MALFUNCTION. ANALYSIS REPORT CONCLUSION 08/12/2022: THE TWO MAIN CAUSES OF THE SCREWDRIVER SHAFT BREAKAGE ARE DUE TO A BENDING STRESS APPLIED TO THE INSTRUMENT BY THE SURGEON DURING SURGERY, AND TORSION STRESS APPLIED TO THE INSTRUMENT BY THE SURGEON DURING SURGERY. THIS PARTICULAR BREAKAGE WAS CAUSED BY TORSION STRESS.

Description of Event or Problem

THE TIPS OF THE ERISMA DRIVERS BROKE OFF WHILE THE DR. INSERTING THE REDUCTION AND SIMULTANEOUSLY PULLING LATERALLY TO RETRACT TISSUE. THE SAME ACTION BROKE TWO DRIVERS IN THE PERIOD OF 5 MINUTES. THERE WAS NO HARM TO THE PATIENT.