SMARTSET GHV GENTAMICIN 40G

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4). 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. H11 ADDITIONAL MANUFACTURER NARRATIVE: D4/G4: DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THEREFORE, (01) GTIN/510K IS NOT AVAILABLE.

Description of Event or Problem

IT WAS REPORTED THAT DURING THE SURGERY, OPENED THE PACKING(DID NOT USE), NOTED THE AMPOULE WAS BROKEN. 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: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. PRODUCT DESCRIPTION- SMARTSET GHV GENTAMICIN 40G. PRODUCT CODE- 3095040. LOT NUMBER- 4618009. DATE OF MANUFACTURING- 30 - OCT - 2024. EXPIRY DATE- 30 - SEPT - 2026. QUANTITY TO BE MANUFACTURED- (B)(4). A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE PRODUCT DESCRIPTION: SMARTSET GHV GENTAMICIN 40G, PRODUCT CODE: 3095040, LOT NUMBER: 4618009, AND THERE WAS 1 NON-CONFORMANCE IDENTIFIED FOR THIS LOT, BUT IT WOULD NOT CONTRIBUTE TO THE COMPLAINT EVENT. 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- SMARTSET GHV GENTAMICIN 40G. PRODUCT CODE- 3095040. LOT NUMBER- 4618009. DATE OF MANUFACTURING- 30 - OCT - 2024. EXPIRY DATE- 30 - SEPT - 2026. QUANTITY TO BE MANUFACTURED- (B)(4). ADDED: D4 EXPIRATION DATE, H4. CORRECTED: D3, D4 PRIMARY UDI NUMBER, E1 FACILITY NAME, G1 MANUFACTURER SITE