RONG SMITH PETERSON STR 9.5"

Additional Manufacturer Narrative

(B)(4). THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION AT THIS TIME. THE MANUFACTURER WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

Description of Event or Problem

SURGEON WAS DOING A RIGHT TOTAL KNEE ON THE PATIENT WITH HARDWARE REMOVAL. THEY WERE USING A RONGEUR AND THE SCREW IN THE JOINT OF THE INSTRUMENT FELL OUT INTO THE KNEE OF THE PATIENT. THE SCREW WAS FOUND. THE SCREW AND RONGEUR WERE REMOVED OFF THE FIELD AND PLACED IN A BIOHAZARD BAG. THE SCREW WAS INSPECTED TO MAKE SURE IT WAS FULL. ALL SCRUBBED EMPLOYEES WERE RE-GLOVED AND THE CASE WENT ON. RISK WAS CALLED AND INFORMED OF WHAT WAS GOING ON. THE RONGEUR WAS PLACED IN THE RISK BIN AT THE OR FRONT DESK. THE PATIENT'S CONDITION IS UNKNOWN.

Additional Manufacturer Narrative

(B)(4). DHR WAS REVIEWED FOR NOTIFICATIONS PERTAINING TO INCOMING INSPECTION, STOCK CHECKS, AND PRODUCT RETURNS. NO CONCERNS WERE NOTED WITH REFERENCE TO 386160. A VISUAL INSPECTION OF THE PRODUCT INVOLVED IN THE COMPLAINT COULD NOT BE CONDUCTED SINCE THE PRODUCT WAS NOT RETURNED. DHR WAS REVIEWED FOR NOTIFICATIONS PERTAINING TO INCOMING INSPECTION, STOCK CHECKS, AND PRODUCT RETURNS. NO CONCERNS WERE NOTED WITH REFERENCE TO 386160. NO CONFIRMED COMPLAINTS WERE RECEIVED IN THIS RANGE WITH THE SAME ISSUE.

Description of Event or Problem

SURGEON WAS DOING A RIGHT TOTAL KNEE ON THE PATIENT WITH HARDWARE REMOVAL. THEY WERE USING A RONGEUR AND THE SCREW IN THE JOINT OF THE INSTRUMENT FELL OUT INTO THE KNEE OF THE PATIENT. THE SCREW WAS FOUND. THE SCREW AND RONGEUR WERE REMOVED OFF THE FIELD AND PLACED IN A BIOHAZARD BAG. THE SCREW WAS INSPECTED TO MAKE SURE IT WAS FULL. ALL SCRUBBED EMPLOYEES WERE RE-GLOVED AND THE CASE WENT ON. RISK WAS CALLED AND INFORMED OF WHAT WAS GOING ON. THE RONGEUR WAS PLACED IN THE RISK BIN AT THE O.R. FRONT DESK. THE PATIENT'S CONDITION IS UNKNOWN.