STLESS STEEL 1X30(75) 5(M7) S/A CPXX

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, 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: D9, H3, H6 INVESTIGATION SUMMARY THE PRODUCT WAS RETURNED TO ETHICON FOR EVALUATION. ONE OPEN BOX WITH SEVEN (7) REPRESENTATIVE UNOPENED SAMPLES WERE RECEIVED FOR ANALYSIS. PRODUCT CODE W995. THE COMPLAINT SAMPLE WAS NOT RECEIVED FOR EVALUATION. IN ORDER TO EVALUATE THE CONDITIONS OF THE RETURNED SAMPLES, THE PACKETS WERE OPENED, AND NO DEFECTS WERE DETECTED. THE SWAGE AND ATTACHMENT AREA WERE NOTED TO BE AS EXPECTED. THE SUTURES WERE DISPENSED WITHOUT PROBLEMS AND EXAMINED ALONG THE STRAND TO DETECT ANY ISSUE RELATED NO DEFECTS WERE OBSERVED DURING EVALUATION. A FUNCTIONAL TEST WAS PERFORMED USING INSTRON EQUIPMENT, AND THE PULL FORCE RESULTS WERE ABOVE THE MINIMUM REQUIREMENTS. THE EVENT DESCRIBED COULD NOT BE CONFIRMED AS THE DEVICE PERFORMED WITHOUT ANY DEFECT NOTED. AS PART OF THE ETHICON QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THE EVENT DESCRIBED COULD NOT BE CONFIRMED AS NO PRODUCT DEFECT WAS IDENTIFIED, THERE MAY HAVE BEEN OTHER CIRCUMSTANCES OR ISSUES THAT OCCURRED DURING THE USE OF THE DEVICE THAT COULD NOT BE REPLICATED DURING THE LABORATORY ANALYSIS. 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 A STERNOTOMY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT SUSPECTED FAULTY STERNAL STEEL WIRES 2 SEPARATE INSTANCES WAS NOTED WHEREIN THE STERNAL WIRE NEEDLE CAME OFF THE WIRE AFTER BEING PULLED THROUGH THE STERNUM. THIS HAS OCCURRED THROUGH DIFFERENT OPERATORS AND INCREASES THE RISK FOR PATIENTS DURING SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 12/4/2025. 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: - DID THE REPORTED ISSUE CONTRIBUTE TO ANY PATIENT ADVERSE CONSEQUENCES? NO PATIENT IMPACT. - PLEASE PROVIDE THE SOURCE OR NAME OF PERSON PROVIDING ANSWERS TO FOLLOW-UP QUESTIONS: (B)(6). 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.