SMARTSET GHV GENTAMICIN 40G

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: THE BONE CEMENT POWDER CLUMPED UPON OPENING THE PACKAGE AND WHEN MIXED WITH THE CEMENT SOLUTION, IT HARDENED QUICKLY. THE TEXTURE WAS ROUGH, MAKING IT UNUSABLE FOR THIS SURGICAL CASE. THE PRODUCT WAS NOT RETURNED TO DEPUY SYNTHES, HOWEVER PHOTOS WERE PROVIDED FOR REVIEW. REVIEW OF THE PHOTOGRAPHIC AND VIDEO EVIDENCE REVEALED THAT THE APPEARANCE OF THE CEMENT POWDER WAS NOT FREE FLOWING, SEVERAL CLUMPS AND AGGLOMERATIONS OF FINE PARTICLES THAT CRUMBLES TO THE TOUCH WERE FOUND. A RETAINED SAMPLE TESTING WAS PERFORMED FOR THIS PRODUCT (3095040) AND LOT (4647943) COMBINATION. THE ASSESSMENT REVEALED THAT THE CEMENT MIXED AND BEHAVED AS EXPECTED FOR THE PRODUCT TYPE AND MET THE APPROPRIATE CONTROL SPECIFICATION. IT IS WORTH NOTICE THAT THE SAMPLE WAS TESTED IN A TEMPERATURE AND HUMIDITY-CONTROLLED LABORATORY. ADDITIONALLY, NO CLUMPING WAS OBSERVED IN THE SAMPLE POWDER PACK. BASED ON THE RESULTS OF THE RETAIN SAMPLE TESTING, THE ROOT CAUSE OF THE COMPLAINT CONDITION CANNOT BE TRACED TO A MANUFACTURING ISSUE. ONCE THE PRODUCT LEAVES J&J MEDTECH ORTHOPEDICS CONTROL, IT IS UNKNOWN WHAT ENVIRONMENT CONDITIONS OR HUMAN INTERVENTION OR MANIPULATION THE PRODUCTS ARE EXPOSED TO DURING THAT TIME. AS PER THE INSTRUCTIONS FOR USE (IFU-0630132 REV. B): "BONE CEMENTS ARE HEAT SENSITIVE. ANY INCREASE OR DECREASE IN TEMPERATURE (EITHER AMBIENT, AND/OR OF THE CEMENT COMPONENTS AND MIXING EQUIPMENT) FROM THE RECOMMENDED TEMPERATURE OF 73 °F (23 °C) WILL AFFECT THE HANDLING CHARACTERISTICS AND SETTING TIME OF THE CEMENT. NOTE: MANUAL HANDLING AND BODY TEMPERATURE WILL REDUCE THE FINAL SETTING TIME. VARIATIONS IN HUMIDITY WILL AFFECT THE CEMENT HANDLING CHARACTERISTICS AND SETTING TIME." ADDITIONALLY, " THE HANDLING CHARACTERISTICS AND SETTING TIME MAY VARY IF THE CEMENT COMPONENTS OR MIXING EQUIPMENT HAVE NOT BEEN FULLY EQUILIBRATED TO 73 °F (23 °C) BEFORE USE. IT IS RECOMMENDED THAT THE UNOPENED PRODUCT IS STORED AT 73 °F (23 °C) FOR A MINIMUM OF 24 HOURS BEFORE USE". HOWEVER, WITH THE AVAILABLE INFORMATION, A POTENTIAL CAUSE OF THE OBSERVED CONDITION OF THE CEMENT POWDER CANNOT BE ESTABLISHED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE PRODUCT DESCRIPTION: SMARTSET GHV GENTAMICIN 40G PRODUCT CODE: 3095040 LOT NUMBER: 4647943 AND NO NON-CONFORMANCES OR MANUFACTURING IRREGULARITIES WERE IDENTIFIED THAT WOULD CONTRIBUTE TO THE REPORTED ISSUE. 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, 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 J&J MEDTECH ORTHOPEDICS 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 PRODUCT DESCRIPTION: SMARTSET GHV GENTAMICIN 40G PRODUCT CODE: 3095040 LOT NUMBER: 4647943 AND NO NON-CONFORMANCES OR MANUFACTURING IRREGULARITIES WERE IDENTIFIED THAT WOULD CONTRIBUTE TO THE REPORTED ISSUE. DEVICE HISTORY REVIEW: A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE PRODUCT DESCRIPTION: SMARTSET GHV GENTAMICIN 40G PRODUCT CODE: 3095040 LOT NUMBER: 4647943 AND NO NON-CONFORMANCES OR MANUFACTURING IRREGULARITIES WERE IDENTIFIED THAT WOULD CONTRIBUTE TO THE REPORTED ISSUE. ADDED: H4. CORRECTED: D3.

Description of Event or Problem

IT WAS REPORTED THAT THE BONE CEMENT POWDER CLUMPED UPON OPENING THE PACKAGE AND WHEN MIXED WITH THE CEMENT SOLUTION, IT HARDENED QUICKLY. THE TEXTURE WAS ROUGH, MAKING IT UNUSABLE FOR THIS SURGICAL CASE. THERE WERE NO PATIENT CONSEQUENCES.

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. THEREFORE, 510K IS NOT AVAILABLE. G4: DMF# - (B)(4) TRADE NAME GENTAMICIN SULPHATE ACTIVE INGREDIENT(S) GENTAMICIN SULPHATE DOSAGE FORM - POWDER STRENGTH 1.0G ACTIVE IN OUR CEMENTS.