STLESS STEEL SIL 4X18IN 6 S/A CCS
Received Jul 16, 2025 · Event occurred Jun 16, 2025
Report 2210968-2025-08187 · MDR key 22518802
Device
Product problems
- Break
- Break
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
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. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED. H6 COMPONENT CODE: G07002 DEVICE NOT RETURNED. 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. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: DR. EXPLAINED TO ME THAT 2 WIRES (DEVICES) BROKE.
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT A STERNOTOMY CLOSURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE MULTIPLE TIMES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. DEVICE WAS DISPOSED OF. ADDITIONAL INFORMATION WAS REQUESTED.