STLESS STEEL SIL 4X18IN 6 S/A V-40

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY A SALES REP THAT, IT WAS FOUND THAT HERE HAD BEEN CONTAMINATION INSIDE OF THE PACKAGE. ANOTHER COMPETITIVE PRODUCT WAS USED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4) DATE SENT TO THE FDA: 1/21/2026 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. ADDITIONAL INFORMATION WAS REQUESTED, THE FOLLOWING WAS OBTAINED: WHERE WAS THE FOREIGN MATERIAL FOUND? (INSIDE THE STERILE BARRIER OR OUTSIDE OF THE STERILE BARRIER?) UNK PLEASE DESCRIBE THE TYPE OF FOREIGN MATTER THAT WAS OBSERVED. WHAT WAS THE FOREIGN MATTER¿S APPEARANCE? UNK. WHAT WAS THE TEXTURE? UNK. ARE THERE ANY PHOTOS OF THE FOREIGN MATTER AVAILABLE? NO HAVE IS IT POSSIBLE THAT THE FOREIGN MATERIAL FELL INTO PACKAGING UPON OPENING OF DEVICE? UNK WAS THE PRODUCT SEAL ON THE FOIL STILL INTACT WHEN THE PACKAGE WAS OPENED? UNK WILL THE DEVICE BE RETURNED FOR EVALUATION? IF YES PLEASE RETURN ALL RELEVANT PACKAGING MATERIAL. PLEASE PROVIDE THE SOURCE OR NAME AND TITLE OF EXTERNAL PERSON PROVIDING ANSWERS TO FOLLOW-UP (EXTERNAL PERSON SUBMITTING ANSWERS TO SALES REP OR LOC/BQ), (B)(6). 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. D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. THE LOT/BATCH WAS NOT PROVIDED; THEREFORE, A MANUFACTURING RECORD EVALUATION COULD NOT BE PERFORMED.