VMP + DEPUY CMW 3G 50G

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. ADDITIONAL NARRATIVE: DMF# - 13704. TRADE NAME ¿ GENTAMICIN SULPHATE. ACTIVE INGREDIENT(S) ¿ GENTAMICIN SULPHATE. DOSAGE FORM - POWDER. STRENGTH ¿ 1.0G ACTIVE IN OUR CEMENTS. D4: UDI: THE EXPIRATION DATE IS CURRENTLY NOT AVAILABLE. THEREFORE, THE FULL UDI IS CURRENTLY NOT AVAILABLE. G4: DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES BUT IS SIMILAR TO DEVICE MARKETED IN THE USA.

Description of Event or Problem

IT WAS REPORTED THAT FACILITY DISCOVERED THAT ONE PACKAGING OF CEMENT WAS DAMAGED.

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. ACCORDING TO THE INFORMATION RECEIVED, ¿I INFORM YOU THAT WE HAVE 1 MORE PACKAGING OF CEMENT (3005050) DAMAGED ¿ LOT 4389524". MANUFACTURING DATE: 2024-02-14, EXPIRY DATE: 2026-01-31, QUANTITY: (B)(4). THERE WAS 1 NON-CONFORMANCE ON THIS LOT. ON REVIEW OF THE APPLICABLE NCS NONE HAVE BEEN IDENTIFIED WHICH WOULD CONTRIBUTE TO THE COMPLAINT EVENT. ALL QC AND MICROBIOLOGY TESTING MET SPECIFICATION. A REVIEW OF THE DHR HAS CONFIRMED THAT THERE WERE NO PROCESS ISSUES DOCUMENTED THAT COULD CONTRIBUTE TO THE EVENT DESCRIBED. 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 REVIEW: MANUFACTURING DATE: 2024-02-14, EXPIRY DATE: 2026-01-31, QUANTITY: (B)(4). THERE WAS 1 NON-CONFORMANCE ON THIS LOT. ON REVIEW OF THE APPLICABLE NCS NONE HAVE BEEN IDENTIFIED WHICH WOULD CONTRIBUTE TO THE COMPLAINT EVENT. ALL QC AND MICROBIOLOGY TESTING MET SPECIFICATION. A REVIEW OF THE DHR HAS CONFIRMED THAT THERE WERE NO PROCESS ISSUES DOCUMENTED THAT COULD CONTRIBUTE TO THE EVENT DESCRIBED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE, AND NO NON-CONFORMANCES / MANUFACTURING IRREGULARITIES RELATED TO THE MALFUNCTION WERE IDENTIFIED. H11 ADDITIONAL NARRATIVE: CORRECTED: H6 (MEDICAL DEVICE PROBLEM CODE).

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY- AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE REPORTED COMPLAINT CONDITION, THEREFORE IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND PREVENTIVE ACTION IS REQUIRED AT THIS TIME. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF THE POST-MARKET SURVEILLANCE. HOWEVER, IF THE PRODUCT IS RECEIVED AT A LATER DATE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. ADDED: D4 (EXPIRY DATE), H4. CORRECTED: D3, D4 (PRIMARY UDI NUMBER), G1.