STLESS STEEL SIL 4X18IN 7 S/A CCS

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE SURGEONS ARE COMPLAINING THAT THE NEEDLE POPS OFF AFTER MAKING ONE PASS THROUGH. NO OTHER DETAILS AND THE SUTURE WAS NOT SAVED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 4/9/2025. H6 COMPONENT CODE: G07002 - DEVICE NOT RETURNED. 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. THE FOLLOWING INFORMATION WAS RECEIVED: UNUSED SUTURES PULLED AND SENDING IN. THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNAVAILABLE: (B)(4) - INITIAL REPORTING FOR "SURGEONS COMPLAINING THAT THE NEEDLE POPS OFF AFTER MAKING ONE PASS THROUGH." (B)(4) - FILE TO CAPTURED THE MULTIPLE EVENTS REPORT. - PLEASE CONFIRM THE NUMBER OF PATIENTS AFFECTED BY THIS ALLEGED DEFICIENCY. - HAVE ANY OF THESE EVENTS BEEN PREVIOUSLY REPORTED TO ETHICON? IF SO, PROVIDE THE RESPECTIVE REFERENCE NUMBER(S). IF NO, PLEASE CREATE A NEW PC FILE FOR EACH PATIENT/EVENT. PLEASE PROVIDE INFORMATION REQUESTED BELOW FOR EACH PATIENT/EVENT. - HOW MANY DEVICES DEMONSTRATED THE ALLEGED DEFICIENCY? - PLEASE CONFIRM IF THE DEVICES ARE AVAILABLE FOR PRODUCT RETURN. IF YES, CONFIRM THE QUANTITY OF DEVICES AVAILABLE FOR PRODUCT ANALYSIS AND PROVIDE THE STATUS OF THE DEVICES AS THEY HAVE NOT BEEN RECEIVED FOR ANALYSIS. IF THE DEVICE HAS BEEN SHIPPED, PLEASE PROVIDE THE SHIPMENT TRACKING DETAILS. - PROVIDE THE SOURCE OR NAME AND TITLE OF EXTERNAL PERSON PROVIDING ANSWERS TO FOLLOW-UP (EXTERNAL PERSON SUBMITTING ANSWERS TO SALES REP). AFTER VARIOUS ATTEMPTS TO GET FURTHER INFORMATION, THEY HAVE NOT PROVIDED ANY. I HAVE THE UNUSED PACKAGES AND WILL RETURN. 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. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS.