FRONT LOADING CARTRIDGE KIT VACUUM MIXING SYSTEM

Additional Manufacturer Narrative

THIS EVENT IS RECORDED WITH ZIMMER BIOMET UNDER (B)(4). ONCE THE INVESTIGATION IS COMPLETE AND/OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW UP MDR WILL BE SUBMITTED. FOLLOW UP ON PRODUCT RETURN IS OPEN.

Description of Event or Problem

IT WAS REPORTED THAT DURING CEMENT LAYING, THE PLASTIC NOZZLE BROKE. THIS EVENT OCCURRED DURING SURGERY AND THE BREAKAGE WAS DURING USE. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THIS MALFUNCTION.

Additional Manufacturer Narrative

THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER (B)(4). THE DEVICE HISTORY RECORD (DHR) FOR THE FRONT LOADING CARTRIDGE KIT FRONT LOADING CARTRIDGE KIT COMPATIBLE WITH ZIMMER® VACUUM MIXING SYSTEM, PART NUMBER 00506905200 AND LOT NUMBER 63589336, REVIEW NOTED NO RELATED NON-CONFORMANCES, REQUESTS FOR DEVIATION (RFD), CHANGE NOTICES (CN), OR ANY OTHER ISSUES WITH MANUFACTURING. THE DHR REVIEW FOUND NO ISSUES WITH THE DEVICE AND ALL VERIFICATIONS, INSPECTIONS, AND TESTS WERE SUCCESSFULLY COMPLETED. ON 26 MAR 2018, IT WAS REPORTED FROM CENTRE HOSPITALIER (B)(6) THAT A FRONT LOADING CARTRIDGE KIT FRONT LOADING CARTRIDGE KIT COMPATIBLE WITH ZIMMER® VACUUM MIXING SYSTEM HAD BROKE AT THE PLASTIC NOZZLE WHILE LAYING CEMENT. A RETURNED PRODUCT INVESTIGATION COULD NOT BE PERFORMED FOR THE REPORTED EVENT DUE TO THE PRODUCT NOT BEING RETURNED FOR EVALUATION. THE REPORTED EVENT CAN, THEREFORE, NOT BE CONFIRMED. THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE SPECIFICALLY DETERMINED WITH THE PROVIDED INFORMATION BECAUSE THE PRODUCT WAS NOT RETURNED FOR EVALUATION. THE INVESTIGATION WAS BASED ON THE INFORMATION THAT WAS PROVIDED INITIALLY AND ANY INFORMATION THAT WAS OBTAINED THROUGHOUT THE FOLLOW-UP PROCESS.