InjuryKWD
BIOPRO GREAT TOE MP JOINT
Received May 15, 2014 · Event occurred May 2, 2014
Report 1833506-2014-00001 · MDR key 3839180
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
70 YR
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
COMPONENT WAS IMPLANTED AFTER STERILE EXPIRATION DATE. EXPIRATION DATE WAS ON 04/2014 AND PRODUCT WAS IMPLANTED ON (B)(6) 2014.
Additional Manufacturer Narrative
FACILITY IMPLANTED THE COMPONENT AFTER THE STERILE EXPIRATION DATE. THEY WERE NOT AWARE OF THIS. CUSTOMER SERVICE AT MANUFACTURER NOTICED THIS WHEN THE ORDER WAS FAXED IN AND DATE WAS ON PATIENT STICKER. CURRENT STERILIZATION VALIDATION WINDOW GIVES A LEEWAY OF 5 MONTHS AFTER EXPIRATION DATE. THEREFORE, MANUFACTURER IS CONFIDENT THAT COMPONENT WAS STILL STERILE.