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. H11 ADDITIONAL NARRATIVE: G4: DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. DMF# - (B)(4) TRADE NAME ¿ GENTAMICIN SULPHATE ACTIVE INGREDIENT(S) ¿ GENTAMICIN SULPHATE DOSAGE FORM - POWDER STRENGTH ¿ 1.0G ACTIVE IN OUR CEMENTS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

Description of Event or Problem

IT WAS REPORTED THAT BEFORE THE SURGERY, OPENED THE PACKING AND NOTED THAT THE INNER PACKING WAS DAMAGED. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THE ITEM WAS NOT USED.

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: INNER PACKING DAMAGED. IT WAS REPORTED THAT BEFORE THE SURGERY, OPENED THE PACKING (DID NOT USE), NOTED THE INNER PACKING WAS DAMAGED(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 J&J MEDTECH ORTHOPAEDICS, HOWEVER PHOTOS WERE PROVIDED FOR REVIEW. THE PHOTO INVESTIGATION REVEALED THAT THE PRIMARY POWDER PACK HAS NOT BEEN SEALED APPROPRIATELY. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE [3095040 / 4494877], AND NO NON-CONFORMANCES OR MANUFACTURING IRREGULARITIES RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. 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 J&J MEDTECH ORTHOPAEDICS 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: A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE [3095040 / 4494877], AND NO NON-CONFORMANCES OR MANUFACTURING IRREGULARITIES RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED.