STLESS STEEL SIL 4X18IN 5 S/A V-40
Received Sep 25, 2025 · Event occurred Aug 7, 2025
Report 2210968-2025-11029 · MDR key 23149064
Device
Product problems
- Material Separation
- Material Separation
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
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 DOCTOR FOUND THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED BEFORE USING SUTURE TO SUTURE THE STERNUM. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Additional Manufacturer Narrative
PRODUCT COMPLAINT #: (B)(4). DATE SENT TO THE FDA: 9/25/2025. H6 COMPONENT CODE: G07002: NO DEVICE PROBLEM FOUND. H6 COMPONENT CODE: C22: PHOTO ANALYSIS. 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. H3 INVESTIGATIONAL SUMMARY: THE PRODUCT WAS RETURNED TO ETHICON FOR EVALUATION. ONE DETACHED NEEDLE AND ONESUTURE WERE RECEIVED FOR ANALYSIS. PRODUCT CODE M650G. AFTER INVESTIGATION OF THE SAMPLE, SHORT INSERTION WAS OBSERVED IN THE STRAND. THE VISUAL INSPECTION CONCLUDED THAT THE COMBINATION OF THE NEEDLE/SUTURE WAS DETACHED FROM THE NEEDLE SINCE THE INSERTION END OF THE SUTURE DID NOT MEET THE REQUIREMENT. TO COMPLEMENT THIS ASSESSMENT, THREE PHOTOS WERE PROVIDE SHOWING ONE DETACHED NEEDLE AND ONE SUTURE. BASED ON THE INFORMATION CURRENTLY AVAILABLE, SHORT INSERTION ISSUE WAS IDENTIFIED AS PULL OUT DURING THE INVESTIGATION OF THE SAMPLE RECEIVED. THIS PRODUCT ISSUE WILL BE ADDRESSED THROUGH THE ETHICON QUALITY SYSTEM. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST-MARKET SURVEILLANCE.