SMARTSET GHV GENTAMICIN 40G

Additional Manufacturer Narrative

PRODUCT COMPLAINT # ==> (B)(4). INVESTIGATION SUMMARY ==> LEAKAGE. IT WAS REPORTED THAT DURING THE SURGERY, OPENED THE PACKING(DID NOT USE), NOTED THE CEMENT LEAKED FROM VIAL(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. SEE ATTACHMENT: (B)(4); (1), (B)(4) (2). THE PHOTOGRAPH OF THE COMPLAINT UNIT WAS FORWARDED TO THE MANUFACTURING SITE J&J MEDTECH BLACKPOOL, FOR A MANUFACTURING INVESTIGATION THE PHOTO INVESTIGATION REVEALED SIGNS OF LEAKAGE OF THE SMARTSET GHV GENTAMICIN 40G VAIL. 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 NR WAS RAISED TO INVESTIGATE THE CURRENT COMPLAINT CONDITION. H11 ADDITIONAL NARRATIVE: ADDED: B5, D4 (EXPIRY DATE), E1 (FACILITY NAME), G1 (MANUFACTURING SITE NAME), H4 CORRECTED: D3, D4 (PRIMARY UDI NUMBER), H6 (MEDICAL DEVICE PROBLEM CODE).

Description of Event or Problem

ADDITIONAL INFORMATION RECEIVED: A. HOW WAS THE CEMENT PREPARED FOR USE? - AT THE BEGINNING OF MIXING THE BONE CEMENT, FIRST ADD THE POWDER AND THEN ADD THE WATER AGENT TO FULLY MIX AND MIX IT FOR USE. B. WHAT EQUIPMENT WAS USED TO PREPARE / MIX THE CEMENT? - USE CEMENT MIXER. C. WHAT WAS THE TIMING TO MIX AND THE TIME BETWEEN MIXING AND SETTING? - THE MIXING TIME IS 25 SECONDS, AND THE MIXING AND SETTING TIME IS ABOUT 14 MINUTES. D. WHAT EQUIPMENT WAS USED TO DELIVER THE CEMENT? -APPLY CEMENT BY HAND. E. WHAT WAS THE STORAGE TEMPERATURE OF THE CEMENT PRIOR TO USAGE? - BELOW 25 °. E. WHAT WAS THE OR TEMPERATURE DURING USE OF THE CEMENT - 21°.

Description of Event or Problem

IT WAS REPORTED THAT DURING THE SURGERY, AFTER PACKING WAS OPENED IT WAS IDENTIFIED THAT THE CEMENT LEAKED FROM VIAL. IT WAS NOT USED. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED?

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. ADDITIONAL NARRATIVE: 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. "DMF# - 13704. 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 REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.