SMARTSET GHV GENTAMICIN 40G

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4) INVESTIGATION SUMMARY LEAKAGE. IT WAS REPORTED THAT DURING THE SURGERY, LEAKAGE WAS FOUND BEFORE OPENING THE INNERMOST PACKAGING (AS THE PHOTO SHOWS). ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THE PRODUCT WAS NOT RETURNED TO DEPUY SYNTHES; HOWEVER, A PHOTO WAS PROVIDED FOR REVIEW. SEE ATTACHMENT (B)(4). THE PHOTO INVESTIGATION REVEALED THAT THE AMBER VIAL APPEARS TO BE DAMAGED AS THERE IS VISIBLE EVIDENCE OF LIQUID SPILLAGE INSIDE THE PACKAGING. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE [3095040 / 4597804] NUMBER, AND NO NON-CONFORMANCES / MANUFACTURING IRREGULARITIES RELATED TO THE COMPLAINT CONDITION WERE IDENTIFIED. THE POTENTIAL CAUSE OF THE OBSERVED COMPLAINT CONDITION CANNOT BE TRACED TO A MANUFACTURING ISSUE. ONCE THE PRODUCT LEAVES DEPUY SYNTHES CONTROL, IT IS UNKNOWN WHAT ENVIRONMENT CONDITIONS OR HUMAN INTERVENTION OR MANIPULATION THE PACKAGED PRODUCTS ARE EXPOSED TO DURING THAT TIME. THEREFORE THE SUSPECTED CAUSE IS TRACED TO TRANSPORT/STORAGE OUTSIDE OF DEPUY SYNTHES CONTROL. AS THE DEVICE WAS NOT RETURNED, AN AS-RECEIVED CONDITION COULD NOT BE ASSESSED, AND A DIMENSIONAL INSPECTION AND DOCUMENT/SPECIFICATION REVIEW WERE NOT COMPLETED. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE SMARTSET GHV GENTAMICIN 40G WOULD CONTRIBUTE TO THE COMPLAINED DEVICE ISSUE. BASED ON THE INVESTIGATION FINDINGS, THE POTENTIAL CAUSE IS TRACED TO TRANSPORT/STORAGE, AND IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE REPORTED COMPLAINT CONDITION. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY LOT A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE [3095040 / 4597804] NUMBER, AND NO NON-CONFORMANCES / MANUFACTURING IRREGULARITIES RELATED TO THE COMPLAINT CONDITION WERE IDENTIFIED. H11 ADDITIONAL NARRATIVE: ADDED: D4 (LOT, EXPIRY DATE), H4 CORRECTED: D3, D4 (PRIMARY UDI NUMBER), G1 (MANUFACTURING SITE NAME)

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: D4: UDI: AS A VALID LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. D4/G4: DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THEREFORE, (01)GTIN IS NOT AVAILABLE. DMF# - 13704. TRADE NAME ¿ GENTAMICIN SULPHATE. ACTIVE INGREDIENT(S) ¿ GENTAMICIN SULPHATE. DOSAGE FORM - POWDER. STRENGTH ¿ 1.0G ACTIVE IN OUR CEMENTS.

Description of Event or Problem

IT WAS REPORTED THAT DURING THE TOTAL KNEE ARTHROPLASTY (TKA) SURGERY, LEAKAGE WAS FOUND BEFORE OPENING THE INNERMOST PACKAGING OF THE ITEM. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.