SURGICAL STAINLESS STEEL SUTURE

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4). ADDITIONAL INFORMATION: D4/G4: DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THEREFORE, (01)GTIN IS NOT AVAILABLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED. ATTEMPTS TO OBTAIN THE DEVICE HAVE BEEN MADE. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DID THE EVENT OCCUR DURING ONE OR MULTIPLE PROCEDURES? MULTIPLE PROCEDURE. IF THIS OCCURRED IN MULTIPLE PROCEDURES: PLEASE CONFIRM THE NUMBER OF PATIENTS AFFECTED BY THE ALLEGED DEFICIENCY. 4 PATIENTS. HAVE ANY OF THESE EVENTS BEEN PREVIOUSLY REPORTED TO ETHICON? IF YES, PROVIDE THE RESPECTIVE REFERENCE NUMBER(S). NO. PLEASE CREATE A NEW PC FILE FOR EACH PATIENT/EVENT. PLEASE SPECIFY WERE TO SUBMIT, PATIENT NAME & DATA. HOW MANY DEVICES DEMONSTRATED THE REPORTED ALLEGED DEFICIENCY? 4 DEVICES. WERE THERE PATIENT CONSEQUENCES? IF YES, PLEASE EXPLAIN. NO. PLEASE PROVIDE THE TITLE OF EXTERNAL PERSON PROVIDING ANSWERS TO FOLLOW-UP (E.G. NURSE, SURGEON, RISK MANAGER). CONSULTANT CARDIOVASCULAR SURGEON: DR. (B)(6). DID THIS EVENT CONTRIBUTE TO ANY PATIENT ADVERSE EVENT? IF YES, PLEASE EXPLAIN. NO ADVERSE EVENT TO ANY PATIENT. PLEASE FIND FOUR PATIENTS AS PER THE SURGEON COMPLAINT. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO RELATED NON-CONFORMANCES WERE IDENTIFIED. NO PRODUCT IS AVAILABLE FOR RETURN. 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.

Description of Event or Problem

IT WAS REPORTED A PATIENT UNDERWENT AN OPEN HEART PROCEDURE ON AN UNKNOWN DATE IN 2026 AND SUTURE WAS USED. THE NEEDLE SEPARATED FROM THE SUTURE DURING SUTURING IN OPEN HEART PROCEDURE.