DISPOSABLE MIXING BOWL AND SPATULA

Additional Manufacturer Narrative

(B)(4). REPORT SOURCE: (B)(6). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565-2020-02973, 0001822565-2020-02974, 0001822565-2020-02975. VISUAL EVALUATION OF THE RETURNED PRODUCTS CONFIRMED THE PRESENCE OF LOOSE BLUE PARTICLES INSIDE THE SEALED POUCH FOR THREE OF THE TWENTY UNITS. THE THREE UNITS CONTAINS EACH ONE LOOSE BLUE PARTICLE. ALL THE BLUE PARTICLES HAVE A SIZE GREATER THAN 0.60 SQ.MM AS MEASURED WITH TAPPI CHART, WHICH IS NOT ACCEPTABLE. THE COMPLAINT IS CONFIRMED COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. THE LIKELY CONDITION OF THE THREE UNITS WHEN THEY LEFT ZIMMER BIOMET CONTROL IS CONSIDERED NON-CONFORMING. THE BLUE PARTICLES LIKELY CAME FROM THE EXCESS FLASH GENERATED DURING THE MOLDING PROCESS OF THE MIXING BOWL AND/OR DURING THE TRIMMING OF THIS EXCESS FLASH. THE ROOT CAUSE OF THE REPORTED ISSUE IS ATTRIBUTED TO A MANUFACTURING ISSUE. THE FOLLOWING ACTIONS WERE PREVIOUSLY INITIATED TO ADDRESS THIS ISSUE, A CHANGE TO MANUFACTURING HAS BEEN IMPLEMENTED TO REDUCE FLASH AND REDUCE TRIMMING. THE REPORTED PRODUCT WAS MANUFACTURED BEFORE THE IMPLEMENTATION OF THIS MANUFACTURING CHANGE. 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 THERE WAS DEBRIS IN THE STERILE PACKAGING. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION. ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.