STLESS STEEL SIL 4X18IN 5 S/A V-40
Received Sep 25, 2025 · Event occurred Jan 1, 2025
Report 2210968-2025-10975 · MDR key 23142126
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). DATE SENT TO THE FDA: 9/25/2025. 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. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT: DID THE REPORTED ISSUE CONTRIBUTE TO ANY PATIENT ADVERSE CONSEQUENCES? PLEASE PROVIDE THE SOURCE OR NAME OF PERSON PROVIDING ANSWERS TO FOLLOW-UP QUESTIONS: WERE THE SUTURES TORN? DID SUTURE BREAKAGE POST-OP OCCUR? DID THE SUTURES HAVE TO BE REMOVED? WAS THERE ANY PATIENT EVENT PRIOR TO SYMPTOMS (COUGHING, FALLING, MOVING)? WHAT MEDICAL/SURGICAL INTERVENTION WAS PERFORMED FOR THE PATIENT SYMPTOMS? WHAT WAS THE DATE OF THE SECOND PROCEDURE? CAN YOU DESCRIBE THE APPEARANCE OF THE SUTURE DURING THE SECOND PROCEDURE? 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.
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IN A CARDIOVASCULAR PROCEDURE THE SURGEON USED THE SUTURE FOR CLOSING STERNOTOMY. THE PATIENT RETURNED TO SURGEON FOR EXTERNAL POSTOPERATIVE VISIT AND MENTIONED THAT SUTURES WERE CUT POSTOPERATIVELY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.