Reamer

Additional Manufacturer Narrative

(B)(4). G2: FOREIGN ¿ DENMARK. H6: PROPOSED COMPONENT CODE: MECHANICAL (G04)- DRILL THE DEVICE LOCATION IS UNKNOWN AT THIS TIME; THEREFORE, IT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL MDR WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT THE ACETABULAR REAMER BROKE. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.