ETHICON

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. IT WAS REPORTED BY DISTRIBUTOR PER ACCOUNT THAT THE PRODUCT WAS SPLITTING. CV PACK THE SUTURE BOOTS WERE BREAKING/SPLITTING IN HALF, UNSAFE WHILE WORKING IN AN OPEN CHEST CAVITY. PACING WIRES- WERE SPLITTING. THE SCRUB TECH REMOVED THE DEFECTIVE ITEMS, ENSURED THE PATIENT WASN'T HARMED, DISCUSSED WITH THE SURGEON AND ESCALATED TO TEAM LEADER. DEVICES ARE NOT AVAILABLE FOR RETURN. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 3/30/2026 THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED. ADDITIONAL INFORMATION WAS REQUESTED, THE FOLLOWING WAS OBTAINED: ¿ HOW MANY DEVICES PER LOT WERE FOUND TO EXHIBIT THE ALLEGED DEFICIENCY? BASED IN THE FACT THAT THE CUSTOMER IS COMPLAINING ABOUT 2 KITS AND EACH KIT HAS 4 TPW20. 109786: 4 109GLZ: 4 ¿ PLEASE PROVIDE THE SOURCE OR NAME AND TITLE OF EXTERNAL PERSON PROVIDING ANSWERS TO FOLLOW-UP (EXTERNAL PERSON SUBMITTING ANSWERS TO SALES REP OR DISTRIBUTOR) IT CAN BE MANAGED THROUGH THIS GMB. ¿ ARE THE PRODUCTS AVAILABLE TO BE RETURNED FOR EVALUATION? IF YES, TO WHO AND WHERE CAN A RETURN KIT BE SEND FOR RECOLLECTION? NO, IT WAS CONFIRMED IN THE COMPLAINT THAT NO SAMPLES WILL BE RETURNED. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT.