DERMATOME AN HANDPIECE

Additional Manufacturer Narrative

THIS COMPLAINT IS RECORDED BY ZIMMER BIOMET UNDER (B)(4). G2 COUNTRY: BELGIUM CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET. ONCE THE PRODUCT IS RETURNED AND THE INVESTIGATION IS COMPLETE, A FOLLOW UP/FINAL REPORT WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT DURING UNKNOWN TIME THE UNIT DELIVERED VERY LOW POWER. IT IS UNKNOWN IF THERE WAS PATIENT IMPACT OR INVOLVEMENT. DUE DILIGENCE IS COMPLETE AS MULTIPLE ATTEMPTS WERE MADE; HOWEVER, NO FURTHER INFORMATION IS AVAILABLE. AS NO ADDITIONAL INFORMATION IS AVAILABLE, WE ARE UNABLE TO PROVIDE FURTHER INFORMATION.