STLESS STEEL SIL 4X18IN 5 S/A CCS

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. H6 COMPONENT CODE: G07002 DEVICE NOT RETURNED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO RELATED NON-CONFORMANCES WERE IDENTIFIED. 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. DID THE PATIENT EXPERIENCE A WOUND DEHISCENCE? CONFIRM THE INITIAL CABG WAS ON (B)(6)2024. WHEN DID THE WOUND BREAKDOWN AND OSTEOPOROSIS OCCUR? IS THE WOUND BREAKDOWN RELATED TO THE USE OF THE WIRE? PLEASE EXPLAIN. IS THE OSTEOPOROSIS RELATED TO THE USE OF THE WIRE? PLEASE EXPLAIN. IS THE BONE CUTTING THROUGH THE CHEST WALL RELATED TO THE USE OF THE WIRE? PLEASE EXPLAIN. WHAT WAS THE PATIENT¿S TISSUE CONDITION (NORMAL, THIN, CALCIFIED, FRAGILE, DISEASED)? WERE THERE ANY PATIENT STRESS FACTORS THAT PRECIPITATED THE EVENT OF STERNUM WIRE BREAKAGE? DID THE OPERATING SURGEON OBSERVE ANY SUTURE DEFICIENCY OR ANOMALY BEFORE, DURING, AFTER THE SUTURE PLACEMENT? PLEASE DESCRIBE THE APPEARANCE OF THE SUTURE DURING THE SECOND PROCEDURE. WHAT SYMPTOMS DID THE PATIENT EXPERIENCE FOLLOWING THE INDEX SURGICAL PROCEDURE? ONSET DATE? OTHER RELEVANT PATIENT HISTORY/CONCOMITANT MEDICATIONS? WHAT IS THE PHYSICIAN¿S OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THIS EVENT? WHAT IS THE PATIENT'S CURRENT STATUS?

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG ON (B)(6)2024 AND SUTURE WAS USED. ON (B)(6)2024, THE SURGEON CHECKED PATIENT STABILITY THROUGH X-RAY AND FOUND STERNUM WIRE BROKEN AT 3 PARTS. STERNUM WIRE WAS STITCHED USING FIGURE OF 8 TECHNIQUE, A TECHNIQUE SURGEON HAD USED FOR MORE THAN 20 YEARS. PATIENT WAS THEN REWIRED ON (B)(6)2024 USING SIMILAR METHOD AND NEW STEEL WIRE FROM NEW BOX. ADDITIONAL INFORMATION WAS REQUESTED.