STLESS STEEL SIL 4X18IN 5 S/A V-40

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, 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. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4) H6 COMPONENT CODE: G07002 - DEVICE NOT RETURNED. 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. ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. 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. 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. 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? ADDITIONAL H11: DID THE PATIENT EXPERIENCE AN ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING OR OOZING? UNKNOWN, DID THE PATIENT REQUIRE REVISION SURGERY OR HARDWARE REMOVAL? UNKNOWN, IF NO, WAS THERE ANY ADDITIONAL MEDICAL INTERVENTION REQUIRED SUCH AS X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS? UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES , PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC.)? UNKNOWN, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY NO, (B)(4), DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE.