VMP + DEPUY CMW 3G 50G

Description of Event or Problem

IT WAS REPORTED THAT CEMENT WAS SENT ON AN UNKNOWN DATE FOR THE SURGERY, AND ONE OF THE PACKAGES HAD THE VIAL BROKEN.

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 NARRATIVE: G4: DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. DMF# - 13704 TRADE NAME ¿ GENTAMICIN SULPHATE. ACTIVE INGREDIENT(S) ¿ GENTAMICIN SULPHATE. DOSAGE FORM - POWDER. STRENGTH ¿ 1.0G ACTIVE IN OUR CEMENTS.. H3, H6 INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. ACCORDING TO THE INFORMATION RECEIVED,¿ CEMENT WAS SENT FOR SURGERY PERFORMED ON THE 4 OF THIS MONTHS, 1 OF THE PACKAGES HAD THE VIAL BROKEN.¿ 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: - VMP + DEPUY CMW 3G 50G. PRODUCT CODE: - 3005050. LOT NO: - 4327844. QUANTITY OF MANUFACTURED: - 680. DATE OF MANUFACTURING: - 12-DEC-2023. EXPIRY DATE: - 30-NOV-2025. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE, AND NO NON-CONFORMANCES / MANUFACTURING IRREGULARITIES WERE IDENTIFIED.