SUTURE UNKNOWN

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 2/11/2026. CORRECTED INFORMATION: B1, H1 - ADDITIONAL INFORMATION WAS RECEIVED THAT THIS EVENT NO LONGER MEETS MALFUNCTION REPORTING CRITERIA. THIS MEDWATCH REPORT IS NO LONGER REPORTABLE. 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 INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC 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.

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4). 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 INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC 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. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. 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 FOLLOWING INFORMATION WAS REQUESTED BUT UNAVAILABLE: COULD YOU PLEASE PROVIDE THE LOT NUMBER AND PRODUCT CODE? DID THE REPORTED ISSUE CONTRIBUTE TO ANY PATIENT ADVERSE CONSEQUENCES?

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT UNDERWENT AN APPENDECTOMY ON (B)(6) 2025 AND SUTURE WA WAS USED. DURING THE PROCEDURE, AFTER CLAMPING THE SUTURE WITH THE NEEDLE HOLDER AND GENTLY PULLING IT, THE SUTURE BROKE. THE NURSE PROMPTLY REPLACED THE SUTURE WITH A NEW ONE TO SUCCESSFULLY COMPLETE THE SUTURING SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.