TENDON SPACER SWANSON/HUNTER 24CM X 3MM FLEXSPAN

Additional Manufacturer Narrative

ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

Description of Event or Problem

IT WAS REPORTED THAT AN EXPIRED IMPLANT WAS IMPLANTED INTO A PATIENT ON (B)(6) 2025 AS PER THE FOLLOWING: THE EXPIRED TENDON SPACER WAS INSERTED INTO THE PATIENT WITH THE SURGEONS KNOWLEDGE AND CONSENT.

Additional Manufacturer Narrative

THE REPORTED EVENT COULD BE CONFIRMED SINCE THE DATE THE DEVICE WAS IMPLANTED WAS CONFIRMED TO BE AFTER THE EXPIRATION. THE PRODUCT WAS NOT RETURNED, HOWEVER EVALUATION OF THE DHR AND LABELING DOES CONFIRM THE EXPIRATION DATE WAS CORRECTLY PRINTED ON ALL LABELS. FURTHERMORE, IT WAS NOTED THE DEVICE WAS NOT A LOAN OR A CONSIGNMENT. THE HOSPITAL TEAM KNOWINGLY IMPLANTED AN EXPIRED ITEM SINCE THEY HAD NO OTHERS AVAILABLE. BASED ON THE INVESTIGATION, THE ROOT CAUSE CAN BE ATTRIBUTED A USER RELATED ISSUE. THE SURGEON KNOWINGLY DECIDED TO USE THE PRODUCT OFF-LABEL. IN GENERAL IT CAN BE STATED THAT IN CASE OF THE EXPIRATION OF SHELF LIFE STRYKER CANNOT GUARANTEE THE PERFORMANCE AND SAFETY FOR USE. THE RISK OF INFECTION WILL INCREASE WITH THE TIME PASSED AFTER THE EXPIRY DATE WHICH IS PRINTED ON THE PACKAGING. A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. NO INDICATIONS OF MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. IF MORE INFORMATION IS PROVIDED, THE CASE WILL BE REASSESSED.

Description of Event or Problem

IT WAS REPORTED THAT AN EXPIRED IMPLANT WAS IMPLANTED INTO A PATIENT ON (B)(6)2025 AS PER THE FOLLOWING - THE EXPIRED TENDON SPACER WAS INSERTED INTO THE PATIENT WITH THE SURGEONS KNOWLEDGE AND CONSENT.