OXFORD MP 04MM DRILL

Additional Manufacturer Narrative

(B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, D9, G3, G6, H2, H3, H6, H11. PRODUCT WAS RETURNED FOR INVESTIGATION. THE PRODUCT EXHIBITED SIGNS OF USE, INCLUDING MARRING OF THE QUICK-CONNECT FEATURE AND A NICK ON THE REMAINING FLUTE EDGE. THE DRILL BIT WAS OBSERVED TO BE FRACTURED, AND NOT ALL FRAGMENTS WERE RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS. REVIEW OF THE COMPLAINT HISTORY IDENTIFIED ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED ITEM AND NO ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED PART AND LOT COMBINATION. COMPLAINTS ARE MONITORED PER COMPLAINT TRENDING PROCESS. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

Description of Event or Problem

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

Description of Event or Problem

IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE DRILL FRACTURED INTO TWO PARTS, AND A PIECE OF THE DISTAL PORTION BECAME LODGED IN THE PATIENT¿S BONE. THE SURGEON DETERMINED THAT ATTEMPTING TO RETRIEVE THE BROKEN FRAGMENT COULD RISK ADDITIONAL BONE DAMAGE; THEREFORE, IT WAS LEFT IN PLACE. THE PROCEDURE THEN CONTINUED AS PLANNED. NO FURTHER PATIENT IMPACT OR ADVERSE CONSEQUENCES HAVE BEEN REPORTED TO DATE. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; NO FURTHER INFORMATION OR PRODUCT HAS BEEN RECEIVED AT THE TIME OF THIS REPORT.

Additional Manufacturer Narrative

(B)(4). G2 - FOREIGN: (B)(6). THE CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.