2G OTOMIMIX

Additional Manufacturer Narrative

ZIMMER BIOMET (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT DURING THE OPERATION THE SURGICAL ASSISTANTS WERE UNABLE TO OPEN THE LIQUID CONTAINER BECAUSE MUCH OF THE LIQUID HAD DRIED UP AND WAS STUCK. THERE WAS NO HARM OR INJURY TO THE PATIENT.

Description of Event or Problem

NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

Additional Manufacturer Narrative

THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. PHOTOS RECEIVED AND REVIEW OF SUPPLIED PHOTOS SHOW: A LABELED AND CAPPED VIAL WITHIN THE OPENED PACKAGE BLISTER, VIAL CONTENTS CANNOT BE SEEN AND NO FURTHER DETERMINATION CAN BE MADE. A LABEL FOR REPORTED ITEM WITH A WHITE LABEL ON TOP OF IT. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THE REPORTED EVENT IS UNCONFIRMED, AS IT PRODUCT STATUS CANNOT BE IDENTIFIED BY PHOTOS. IF ANY FURTHER INFORMATION IS FOUND THAT WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. THIS REPORT IS BEING SUBMITTED TO UPDATE ADDITIONAL INFORMATION IN SECTIONS B4, B5, G3, G6, H2, H3, H4, H6, AND H11.