ERISMA-LP

Additional Manufacturer Narrative

ON (B)(6) 2025 - THE POLYAXIAL SCREW DISASSEMBLED INTRAOPERATIVELY WHILE BEING MANEUVERED, RESULTING IN AN UNANTICIPATED INTERRUPTION OF THE SURGICAL PROCEDURE. WHILE THE DISASSEMBLY WAS IDENTIFIED BY THE SURGEON AND THE COMPONENT WAS REMOVED AND REPLACED, THIS EVENT REQUIRED ADDITIONAL SURGICAL INTERVENTION. ALTHOUGH THE PROCEDURE WAS COMPLETED WITHOUT IMMEDIATE HARM TO THE PATIENT, THE EVENT CONSTITUTES A MALFUNCTION OF A MEDICAL DEVICE THAT, IF IT WERE TO RECUR, COULD LEAD TO SERIOUS INJURY OR REQUIRE SURGICAL INTERVENTION TO PREVENT PERMANENT IMPAIRMENT OR DAMAGE TO A BODY STRUCTURE. THIS EVENT IS REPORTABLE AS A MALFUNCTION.

Description of Event or Problem

THE TECH HAD TROUBLE LOADING THE SCREW ON TO THE NAV DRIVER (B)(6). DURING INSERTION OF THE 9.5X80MM SCREW INTO S2AI (S-2 ALAR ILIAC), THE TULIP HEAD SEPARATED FROM THE BONE SCREW AT THE POINT OF BEING 80% INSERTED. THE T20 SCREWDRIVER WAS THEN USED TO REMOVE THE BONE SCREW. A NEW SCREW WAS USED, AND THE SURGERY WAS COMPLETED WITHOUT FURTHER INCIDENT. THERE WAS NO NOTABLE DELAY TO THE SURGERY AND NO COMPLICATIONS FOR THE PATIENT.

Description of Event or Problem

THE TECH HAD TROUBLE LOADING THE SCREW ON TO THE NAV DRIVER (48710003). DURING INSERTION OF THE 9.5X80MM SCREW INTO S2AI (S-2 ALAR ILIAC), THE TULIP HEAD SEPARATED FROM THE BONE SCREW AT THE POINT OF BEING 80% INSERTED. THE T20 SCREWDRIVER WAS THEN USED TO REMOVE THE BONE SCREW. A NEW SCREW WAS USED, AND THE SURGERY WAS COMPLETED WITHOUT FURTHER INCIDENT. THERE WAS NO NOTABLE DELAY TO THE SURGERY AND NO COMPLICATIONS FOR THE PATIENT.

Additional Manufacturer Narrative

(B)(6) 2025 - THE POLYAXIAL SCREW DISASSEMBLED INTRAOPERATIVELY WHILE BEING MANEUVERED, RESULTING IN AN UNANTICIPATED INTERRUPTION OF THE SURGICAL PROCEDURE. WHILE THE DISASSEMBLY WAS IDENTIFIED BY THE SURGEON AND THE COMPONENT WAS REMOVED AND REPLACED, THIS EVENT REQUIRED ADDITIONAL SURGICAL INTERVENTION. ALTHOUGH THE PROCEDURE WAS COMPLETED WITHOUT IMMEDIATE HARM TO THE PATIENT, THE EVENT CONSTITUTES A MALFUNCTION OF A MEDICAL DEVICE THAT, IF IT WERE TO RECUR, COULD LEAD TO SERIOUS INJURY OR REQUIRE SURGICAL INTERVENTION TO PREVENT PERMANENT IMPAIRMENT OR DAMAGE TO A BODY STRUCTURE. THIS EVENT IS REPORTABLE AS A MALFUNCTION. 10/16/2025 - ANALYSIS REPORT CONCLUSION: THE DETAILED CONTEXT OF THE SURGERY WAS NOT AVAILABLE SO IT WAS NOT POSSIBLE TO DETERMINE IF THE SURGERY WAS PERFORMED ACCORDING TO THE SURGICAL TECHNIQUE. AN EXCESSIVE TORQUE APPLIED TO THE SCREWDRIVER MAY HAVE CONTRIBUTE TO SCREW DISASSEMBLY WITHOUT CERTAINTY ABOUT THE CONTEXT HOW IT COULD HAVE BEEN HAPPENED. THIS IS CONSIDERED AS AN ISOLATED CASE DUE TO THE RARE OCCURRENCE (7 CASES IN 5 YEARS) ACCORDING TO FIGURE 1 WITH NO IMPACT ON RISK ANALYSIS. CLARIANCE WILL CONTINUE TO MONITOR THIS TYPE OF EVENT AS PART OF ITS PMS ACTIVITIES AND TREND MONITORING.