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: G4: DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. G4: 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 SMARTSET GHV GENTAMICIN 40G WAS FOUND TO HAVE COMPROMISED STERILITY AND DAMAGED PACKAGING DURING A SURGICAL PROCEDURE. THE INNER PACKAGING WAS FOUND DAMAGED, WITH THE SEAL OF THE BONE CEMENT POWDER PACKAGE NOT COMPLETELY SEALED, RESULTING IN POWDER LEAKAGE. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY, AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE COMPLAINT DEVICE WAS NOT IMPLANTED AND WAS REPLACED INTRAOPERATIVELY.

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: INNER PACKING DAMAGED. IT WAS REPORTED THAT DURING THE SURGERY, THE SEAL OF THE BONE CEMENT POWDER PACKAGE WAS NOT COMPLETELY SEALED, AND THE POWDER INSIDE LEAKED OUT (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, PHOTOS WERE PROVIDED FOR REVIEW. SEE ATTACHMENT (B)(4). THE PHOTO INVESTIGATION REVEALED THAT THE POWDER COMPONENT EXHIBITED A BURST SEAL, WITH EVIDENCE OF POWDER INGRESS THROUGH THE COMPROMISED SEAL. 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 HAVE CONTRIBUTED TO THE COMPLAINED DEVICE ISSUE. BASED ON THE INFORMATION CURRENTLY AVAILABLE, A PRODUCT ISSUE WAS IDENTIFIED DURING THE INVESTIGATION. THIS PRODUCT ISSUE WILL BE ADDRESSED THROUGH DEPUY SYNTHES QUALITY SYSTEM. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY LOT: NR WAS RAISED TO INVESTIGATE CURRENT COMPLAINT CONDITION.