SUT ACIFLEX*2-0 45CM 1AG.CP-35

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, 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. THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNAVAILABLE: THE COMPLAINT IN QUESTION WAS RECEIVED THROUGH AN ANONYMOUS REPORT, SO WE DON'T HAVE THE CONTACT INFORMATION OF THE COMPLAINANT AND WE DON'T HAVE THE ANSWERS TO THE QUESTIONS BELOW. - WHERE WAS THE FOREIGN MATERIAL FOUND? (INSIDE THE STERILE BARRIER OR OUTSIDE OF THE STERILE BARRIER?) - PLEASE DESCRIBE THE TYPE OF FOREIGN MATTER THAT WAS OBSERVED. WHAT WAS THE FOREIGN MATTER¿S APPEARANCE? WHAT WAS THE TEXTURE? - ARE THERE ANY PHOTOS OF THE FOREIGN MATTER AVAILABLE? - IS IT POSSIBLE THAT THE FOREIGN MATERIAL FELL INTO PACKAGING UPON OPENING OF DEVICE? - WAS THE PRODUCT SEAL ON THE FOIL STILL INTACT WHEN THE PACKAGE WAS OPENED? - WILL THE DEVICE BE RETURNED FOR EVALUATION? IF YES PLEASE RETURN ALL RELEVANT PACKAGING MATERIAL. - WAS THE PROCEDURE COMPLETED WITHOUT ANY ADVERSE EFFECT TO THE PATIENT? - PLEASE CONFIRM THE LOT NUMBER OF THE PRODUCTS INVOLVED IN THIS COMPLAINT: - PLEASE PROVIDE THE SOURCE OR NAME OF PERSON PROVIDING ANSWERS TO FOLLOW-UP QUESTIONS: 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. D4: UDI: THE EXPIRATION DATE IS CURRENTLY NOT AVAILABLE. THEREFORE, THE FULL UDI IS CURRENTLY NOT AVAILABLE.

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN OPENING THE PACKAGE, DIRT IS OBSERVED ON TWO PARTS OF THE ACIFLEX WIRE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4). CORRECTED INFORMATION: D4 LOT. ADDITIONAL INFORMATION: D 4. PRIMARY UDI NUMBER. 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 NUMBER PROVIDED, BRRM51921, IS INVALID. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR PART 803, PART 4 SUBPART B. 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.