OXFORD MP 04MM DRILL

Additional Manufacturer Narrative

(B)(4). G2: FOREIGN - EVENT OCCURRED IN CANADA. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT DURING INTRA-OPERATIVE DRILLING OF THE FEMORAL CONDYLE, THE DRILL BROKE AND THE BROKEN PIECE WAS RETRIEVED. THERE WERE NO CONSEQUENCES OR IMPACT TO THE PATIENT, AND NO FRAGMENTS WERE RETAINED. NO FURTHER INFORMATION IS AVAILABLE.