OXFORD UNI FEMORAL DRILL 6.35 MM

Additional Manufacturer Narrative

(B)(4). G2 - FOREIGN: JAPAN. THE CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT DURING THE PROCEDURE, THE DEVICE FRACTURED INTO TWO PIECES DURING DRILLING. NO FOREIGN MATERIAL WAS RETAINED IN THE PATIENT, AND THE PROCEDURE WAS COMPLETED USING AN ALTERNATIVE INSTRUMENT. THERE WERE NO REPORTED ADVERSE CONSEQUENCES OR HEALTH IMPACTS TO THE PATIENT. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; NO FURTHER ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED AT THE TIME OF THIS REPORT.