CADWELL

Description of Event or Problem

TECHNOMED RECEIVED COMPLAINT VIA DISTRIBUTOR CADWELL 10 MARCH 2026 WITH REGARDS TO THE SUBDERMAL NEEDLE PART NUMBER: 302875-000 (NEEDLE, PARALLEL,14X0.38MM (27G) 100IN12PR), EITHER LOT: 103210: THE COMPLAINT IS THAT THE NEEDLE BROKE OFF IN THE PATIENT, REQUIRING AN ADDITIONAL PROCEDURE TO REMOVE IT. THE EVENT DATE WAS TODAY, MARCH 10TH. "WHILE REMOVING NEEDLES AT THE END OF THE CASE, I NOTICED ONE SHARP HAD BROKEN OFF ABOVE THE HUB FROM THE LEFT VL MUSCLE. I CHECKED THE TAPE AND SURROUNDING AREA BUT COULD NOT FIND THE SHARP. I IMMEDIATELY NOTIFIED THE RN AND RESIDENT WHO WAS STILL IN THE ROOM. WE BOTH FELT AROUND THE INSERTION AREA (WHICH ALSO SHOWED TWO BURN MARKS); NEITHER OF US COULD FEEL THE NEEDLE AND WE WERE NOT CERTAIN IT WAS IN THERE. I SUGGESTED WE ASK (B)(6) TO COME BACK IN THE ROOM TO CONFIRM THE SHARP WAS NO LONGER IN THE PATIENT. THE RESIDENT AGREED. FLAT PLATE IMAGES WERE TAKEN AND THE BROKEN SHARP WAS LOCATED. DR. (B)(6) CAME BACK INTO THE OPERATING ROOM AND PERFORMED ANOTHER PROCEDURE TO REMOVED THE SHARP. THIS ENDED UP IN AN ADDITIONAL HOUR OF OPERATING ROOM TIME, ADDITIONAL (B)(6) TIME, ADDITIONAL LOCAL ANESTHETIC, SILVER NITRATE MATCHSTICKS FOR HEMOSTASIS AND TWO 2.0 MONOCRYLS. " THE EVENT OCCURED DURING THE FOLLOWING PROCEDURE: T10-PELVIS POSTERIOR FUSION.