POWERPUMP DAY CASSETTE 10PK

Additional Manufacturer Narrative

CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT.

Description of Event or Problem

DURING AN ARTHROSCOPY PROCEDURE, THE CASSETTE WAS REPORTED TO BE LEAKING FLUID. ANOTHER CASSETTE WAS UTILIZED TO COMPLETE THE PROCEDURE. THERE WAS NO HARM TO THE PATIENT.

Additional Manufacturer Narrative

THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. (B)(4). MANUFACTURE DATE: UNKNOWN DATE, JANUARY 2016. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION(S) IS/ARE REQUIRED. ROOT CAUSE WAS DETERMINED BY SUPPLIER INVESTIGATION TO BE USER RELATED. 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.