HEMICAP PATELLO-FEMORAL RESURFACING PROSTHESIS

Additional Manufacturer Narrative

THE RISK INVOLVED WITH SEIZED BROKEN PIN TIPS IS MINIMAL AS THE GUIDE PINS ARE MANUFACTURED USING IMPLANT GRADE (B)(4) STAINLESS STEEL (PER ASTM F138) MATERIAL. BASED ON THE INVESTIGATION RESULTS, IT APPEARS THAT EXCESSIVE FORCE MAY HAVE BEEN USED WHILE EXTRACTING THE PINS FROM THE GUIDE BLOCK. THE LOT WAS MANUFACTURED TO SPECIFICATIONS; MANUFACTURING RECORDS INCLUDING MATERIAL CERTIFICATES, INSPECTION RECORDS., ETC WERE REVIEWED AND NO ISSUES WERE NOTED. THE SURGEON DECIDED TO LEAVE THE PIECES IN AND COMPLETED THE CASE WITH NO OTHER ISSUES. SHOULD ARTHROSURFACE RECEIVE ANY ADDITIONAL INFORMATION REGARDING THIS CASE, THE INVESTIGATION WILL BE RE-OPENED AND REPORTED THROUGH A SUPPLEMENTAL MDR.

Description of Event or Problem

TWO GUIDE PINS BROKE WHILE PREPARING THE PFXL HEMICAP IMPLANT SITE. THE PINS WERE SEIZED IN PATIENT'S BONE AND WERE NOT RETRIEVED.