Description of Event or Problem · 1
HISTORY: TOE IMPLANTS WERE RECEIVED INTO SPD FOR VALIDATION IN 2009 FOR A CONSIGNMENT STOCK FOR USE BY PODIATRIST. PACKAGING AND EXPIRATION DATE WAS VALIDATED BY SPD TECHNICIAN THE SAME DAY, AND THE IMPLANTS WERE DELIVERED TO THE OR WITH A VALIDATION STICKER ON THE PACKAGE. THE CASE IN QUESTION WAS SCHEDULED FOR THE AFTERNOON OF TWENTY DAYS PRIOR. POSITION OF THE IMPLANT WAS VERIFIED PRE OPERATIVELY BY NURSE AND THE SURGEON WAS NOTIFIED. THE PROCEDURE WAS STARTED, AND THE TOE WAS READIED TO RECEIVE THE IMPLANT, AT WHICH TIME NURSE OPENED THE OUTER, UNSTERILE, PACKAGE TO FIND AN INNER STERILE PACKAGE WITH A DIFFERENT OUTDATE AND DIFFERENT LOT NUMBER THAN THE OUT PACKAGE STATED. THE MANUFACTURER WAS IMMEDIATELY CONTACTED TO EXPLAIN THE DILEMMA. THE QA SPOKESPERSON EXPLAINED THEIR QA HAD VALIDATED THE LOT NUMBERS -BOTH- AS BEING LOTS THAT HAD AND EXTENDED OUTDATE OF TWO YEARS, AND THE IMPLANT WAS GOOD UNTIL 2009. THE QA SPOKESPERSON FAXED TWO SEPARATE MEMOS FOR WRITTEN VERIFICATION OF THE DATE EXTENSION. THE IMPLANT WAS OPENED AFTER VERIFICATION BY FAX FROM THE VENDOR WAS RECEIVED, AND IMPLANTED INTO THE PATIENT. THERE WAS APPROXIMATELY A 20 MINUTE DELAY WHILE WAITING FOR THE PRODUCT VALIDATION. THE CHIEF OF SPD ATTEMPTED TELEPHONE CONTACT WITH THE VENDOR TO REQUEST EVIDENCE OF STUDY SHOWING EXTENSION OF STERILITY, BUT THERE WAS NO ANSWER. RECOMMENDATIONS: REPORT INFORMATION TO THE FDA FOR POSSIBLE RECALL ACTION THE FOLLOWING REASONS: MEDICAL DEVICE - IMPLANT- WAS MISLABELED, I.E. A-WRONG EXPIRATION DATE ON OUTER PACKAGE -2013/05-. WRONG LOT NUMBER LISTED ON OUTER PACKAGE. DIFFERENT LOT NUMBER ON THE STERILE INNER PACKAGE. INNER PACKAGE EXPIRATION DATE NOTED AS 2007/09. DURING PHONE CONVERSATION BETWEEN NURSE AND QA SPOKESPERSON, THE SPOKESPERSON STATED A RECALL HAD BEEN INITIATED AT SOME EARLIER DATE; NO INFORMATION WAS LOCATED ON THE FDA WEB SITE ABOUT A RECALL OF THIS PRODUCT.