SMARTSETGMV ENDURANCE GENT 40G

Additional Manufacturer Narrative

THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). 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 DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

Description of Event or Problem

IT WAS REPORTED THAT DURING THE SURGERY, NOTED THAT THE WATER AGENT WITH BLACK IMPURITIES. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED. ¿

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: ACCORDING TO THE INFORMATION RECEIVED,¿ FOREIGN MATTER. IT WAS REPORTED THAT DURING THE SURGERY, NOTED THAT THE WATER AGENT WITH BLACK IMPURITIES. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY¿. NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. PRODUCT DESCRIPTION: - SMARTSETGMV ENDURANCE GENT 40G. PRODUCT CODE: - 3105040. LOT NO: - 4467637. QUANTITY OF MANUFACTURED: - (B)(4). DATE OF MANUFACTURING: - 3-JUNE-2024. EXPIRY DATE: - 31-MAY-2027. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF THE POST-MARKET SURVEILLANCE. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE HISTORY LOT: PRODUCT DESCRIPTION: - SMARTSETGMV ENDURANCE GENT 40G. PRODUCT CODE: - 3105040. LOT NO: - 4467637. QUANTITY OF MANUFACTURED: - (B)(4). DATE OF MANUFACTURING: - 3-JUNE-2024. EXPIRY DATE: - 31-MAY-2027. DEVICE HISTORY BATCH: NULL. DEVICE HISTORY REVIEW: A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 4467637, AND NO NON-CONFORMANCES / MANUFACTURING IRREGULARITIES WERE IDENTIFIED. ADDED: D3, D4 (EXPIRATION DATE), G1, H4. CORRECTED: D4 (PRIMARY UDI NUMBER).