DIGITAL COMPRESSION SCREW

Additional Manufacturer Narrative

(B)(6) CENTER DID NOT VERIFY THE EXPIRATION DATE OF THE IMPLANT IN QUESTION PRIOR TO IMPLANTING IT. BIOPRO ATTEMPTED TO RETRIEVE THIS SPECIFIC ITEM PRIOR TO EXPIRATION AND WAS TOLD THAT (B)(6) DID NOT HAVE IT. (B)(6) DID INDEED HAVE IT AND PROVIDED IT TO (B)(6) CENTER AND IT WAS IMPLANTED AFTER THE DATE OF EXPIRATION. THE EXPIRATION DATE WAS CLEARLY VISIBLE ON THE LABEL. THE FOLLOWING LETTER WAS PREPARED AND PROVIDED TO (B)(6): RE: DIGITAL COMPRESSION SCREW, ITEM NUMBER 17111, LOT # 107903, EXPIRATION DATE 07-2016. AT THE TIME OF IMPLANTATION IN (B)(6) 2016, THE LABEL ON THIS COMPONENT INDICATED THAT THE PART WAS BEYOND ITS EXPIRATION DATE. THIS EXPIRATION DATE IS IN RELATION TO THE STERILE PACKAGING, NOT THE ACTUAL COMPONENT. THE SHELF LIFE FOR PRODUCT UTILIZING TYVEK POUCHES LIKE THE DCS IS PACKAGED IN HAS BEEN ESTABLISHED BY BIOPRO TO BE 7 YEARS FROM DATE OF PACKAGING. THIS TIME WAS ESTABLISHED IN 2003 AS A RESULT OF A REAL TIME AGING TEST CONDUCTED BY AN OUTSIDE CONTRACTOR. THE PIECES TESTED WERE AT THAT TIME UP TO 7 YEARS AND 7 MONTHS POST PACKAGING, WHICH EXCEEDS THE 7 YEAR AND 3 MONTH AGE OF THE PIECE IN QUESTION. TEST RESULTS OF ALL COMPONENTS OF THE REAL TIME AGING TEST WERE REVIEWED AND ALL PIECES TESTED MET OR EXCEEDED THE ACCEPTANCE CRITERIA TO BE CONSIDERED STERILE. BASED ON THE TESTING CONDUCTED AND THE AGE OF THE PIECE IMPLANTED I AM CERTAIN THAT THE DEVICE IN QUESTION MAINTAINED ITS STERILITY AND THERE IS NO RISK TO THE PATIENT. DEVICE IS IMPLANTED AND NOT AVAILABLE.

Description of Event or Problem

(B)(6) CENTER HAD A PATIENT ON THE TABLE FOR A DCS IMPLANT AND HAD FAILED TO OBTAIN AN IMPLANT FOR THE SURGERY. (B)(6), THE SALES REP IN THAT AREA, DID NOT HAVE ANY INVENTORY ON HAND. (B)(6) CONTACTED (B)(6) WHOM WAS ABLE TO PROVIDE AN IMPLANT FOR THE SURGERY. THE ITEM THEY PROVIDED WAS LOT # 107903, PART NUMBER 17111. THIS ITEM WAS PACKAGED IN JULY OF 2009 AND EXPIRED IN JULY OF 2016. (B)(6) WAS CONTACTED BY BIOPRO IN EARLY 2016 TO SEND THAT INVENTORY BACK, (B)(6) INDICATED THAT THEY HAD NO INVENTORY OF THAT LOT NUMBER AND BIOPRO WAS UNABLE TO RETRIEVE IT FOR REPACKAGING. (B)(6) KEPT EXPIRED INVENTORY, (B)(6) RECEIVED THE INVENTORY, WHICH WAS LABELED, AND NEVER CHECKED THE EXPIRATION DATE ON THE LABEL PRIOR TO IMPLANTATION. THIS LOT # DID INDEED EXPIRE IN JULY OF 2016; THE JOB PACKET WITH THE LABEL IS ATTACHED TO THE COMPLAINT. UPON REVIEW OF THE REAL TIME AGING STUDY FOR THE TYVEK POUCHES IT WAS NOTED THAT ALTHOUGH BIOPRO HAS ESTABLISHED THE SHELF LIFE FOR THE POUCHES AT 7 YEARS, MANY OF THE PIECES THAT WERE TESTED TO DETERMINE THIS WERE ACTUALLY AGED TO 7 YEARS AND 7 MONTHS. THE COMPLETE REAL TIME AGING STUDY IS LOCATED IN REGULATORY AFFAIRS. THE AGING STUDY WAS CONDUCTED IN OCTOBER OF 2003 AND THE SAMPLES TESTED WERE PACKED FROM MARCH, 1996 THROUGH JANUARY, 1998. THE EXPIRATION DATE IS CLEARLY MARKED ON THE DCS LABEL, BUT IT IS SMALL. THE CURRENT VERSION OF THE DCS LABEL IS LARGER AND THE EXPIRATION DATE IS MORE PRONOUNCED.