OSTEOWRAP

Description of Event or Problem

THE PATIENT ENTERED THE OPERATING ROOM (OR) FOR SURGERY. THE REPRESENTATIVE CAME, BRINGING THE ALLOGRAFT PACKAGES, REMOVED THE ALLOGRAFT IMPLANTS FROM THE BOX AND GAVE THE CONTENTS TO THE OR REGISTERED NURSE (RN). NO PROBLEM WITH STERILE PACKAGING. IMPLANTS WERE USED. LATER WHEN FILLING OUT THE PATIENT HUMAN TISSUE IMPLANT RECORD IT WAS DISCOVERED THAT THE BACTERIN PAPERWORK HAD ALREADY BEEN FILLED IN WITH ANOTHER PATIENT'S INFORMATION. APPARENTLY THE TISSUE TRACKING FORM HAD BEEN FILLED OUT BY A SALES REPRESENTATIVE BUT THE TISSUE HAD NOT BEEN IMPLANTED. THE REPRESENTATIVE NOTIFIED THE COMPANY WHO TOLD HIM THAT IT IS NOT UNCOMMON TO RECEIVE UNUSED PRODUCT AND RETURN IT TO THEIR SHELVES FOR REDISTRIBUTION. THE BOX HAD NO SEAL, AND WAS QUITE WORN. WE WERE CONCERNED THAT WE RECEIVED A PREVIOUSLY OPENED PRODUCT, NO SEAL, WITH ANOTHER PATIENT'S INFORMATION ON THE CARD.