EXACTECH STEM

Description of Event or Problem

PLEASE BE ADVISED THAT WHILE INVESTIGATING AN EVENT INVOLVING ONE OF OUR PRODUCTS, (B)(6) NOTED A POTENTIAL ADVERSE EVENT REGARDING A NON-(B)(6) PRODUCT. IT WAS REPORTED THAT THE SURGEON WAS REVISING AN EXACTECH N.P. THE EXCESS IMPLANT FELL ON THE FLOOR. TRAY DID NOT HAVE A REPLACEMENT. THE SURGEON EXPECT TO PUT A DEPUY DELTA TS 36+15 HEAD ON AN EXACTECH STEM. THE SURGEON AND EVERYONE IN THE ROOM WAS TOLD THIS WAS OFF LABEL. THE SURGEON ELECTED TO PROCEED AND HAD THE NURSE OPEN THE IMPLANT. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).