SURGICAL STAINLESS STEEL SUTURE

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 4/22/2026. 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. H6 COMPONENT CODE: G07002 NO DEVICE PROBLEM FOUND. ADDITIONAL INFORMATION: D9, H3, H6. H3 INVESTIGATIONAL SUMMARY: THE PRODUCT WAS RETURNED TO ETH FOR EVALUATION. VISUAL INSPECTION REVEALED THAT ONE NEEDLE SUTURE PIECE WAS RECEIVED FOR ANALYSIS. PRODUCT CODE M653. DURING VISUAL INSPECTION OF THE RETURNED SAMPLE, THE END SUTURE WAS NOTED TO BE CUT LIKELY CAUSED BY A SURGICAL INSTRUMENT. NO EVIDENCE OF SUTURE BREAKAGE WAS IDENTIFIED DURING THE EVALUATION. HOWEVER, THE NEEDLE WAS NOTED TO BE BROKEN AT THE TIP AREA. ADDITIONALLY, CRIMPING TOOLING MARKS WERE FOUND ON THE NEEDLE. AS PART OF THE ETHICON QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. PER THE CONDITIONS OF THE RETURNED SAMPLE, NO CONCLUSION COULD BE REACHED DUE TO THE SAMPLE NEEDS ADDITIONAL EVALUATION BY HSA. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS IS CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST-MARKET SURVEILLANCE.

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT UNDERWENT AN CARDIAC PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. 2 PIECES OF STERNAL WIRES FROM THE SAME PACKET WERE FAULTY. THE WIRE BROKE OFF WHEN CLOSING THE STERNUM. 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. ADDITIONAL INFORMATION WAS REQUESTED, THE FOLLOWING WAS OBTAINED: - WERE THERE ANY PATIENT CONSEQUENCES? - UNKNOWN, NOT PRESENT IN CASE - WHAT IS THE PROCEDURE NAME? - CARDIAC PROCEDURE, STERNAL WIRE USED TO CLOSE CHEST - PLEASE PROVIDE THE TITLE OF EXTERNAL PERSON PROVIDING ANSWERS TO FOLLOW-UP (E.G. NURSE, SURGEON, RISK MANAGER). - SISTER MANJU 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. D4/G4: DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THEREFORE, (01)GTIN IS NOT AVAILABLE. THE LOT/BATCH WAS NOT PROVIDED; THEREFORE, A MANUFACTURING RECORD EVALUATION COULD NOT BE PERFORMED.