GPS III SINGLE KIT W/30ML ACDA

Additional Manufacturer Narrative

(B)(4). COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS NOT CONFIRMED. BASED ON DEVICE HISTORY RECORDS, THE PRODUCT WAS MADE TO PRINT AND CORRECT MATERIALS. PRODUCT LEFT CONFORMING TO PRINT AS THERE WAS NO EVIDENCE THAT STATES OTHERWISE. THE GPS KIT HAD AN OPENED STERILE COMPONENT AS STATED IN THE COMPLAINT. THE SEAL ON THE ITEM IN QUESTION SHOWS AN INITIAL PERFECT SEAL WITH NO ¿BIRD EGGS¿ THAT WOULD CAUSE A SEAL TO FAIL. THE ANTICOAGULANT SOLUTION ALSO HAS A NEEDLE MARK ON THE CONTAINER SHOWING IT HAS BEEN USED. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO WERE TRENDS IDENTIFIED. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT THIS TYPE OF EVENT CAN OCCUR AND RISKS ARE ADDRESSED IN RISK DOCUMENTATION. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

Description of Event or Problem

IT WAS REPORTED THAT DURING A TOTAL HIP ARTHROPLASTY, THE GPS KIT WAS OPENED AND ONE OF THE STERILE COMPONENTS WAS ALREADY OPENED. ANOTHER UNIT WAS USED TO COMPLETE THE PROCEDURE WITHOUT DELAY. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.