ADJUSTMENT SOCKET

Description of Event or Problem

ON THE 6TH OF MAY 2025, THE DISTRIBUTOR IN ITALY CONTACTED THE MANUFACTURER, EPISURF OPERATIONS AB, REGARDING A LABEL OF AN INSTRUMENT, PART OF CASE ID T0S0-01, SPECIFYING THAT BOTH THE MANUFACTURING DATE AND EXPIRY DATE WERE 2025-04.THE EVENT INVOLVED AN ADJUSTMENT SOCKET DEVICE THAT IS NOT MARKETED IN THE UNITED STATES (US).AFTER REVIEWING THE CERTIFICATE OF CONFORMANCE (COC), SPECIFYING THAT THE PRODUCT WAS STERILIZED ON THE 15TH OF APRIL 2025, THIS CONFIRMED THAT THE PRODUCT'S EXPIRY DATE WAS 2026-04, INSTEAD OF THE INCORRECTLY SPECIFIED 2025-04, AS THE SHELF-LIFE OF THE DEVICE IS 12 MONTHS AFTER STERILIZATION HAS BEEN PERFORMED.ON THE 6TH OF MAY 2025, THE MANUFACTURER CONFIRMED THAT THE DEVICE HAD NOT EXPIRED AND A CORRECTED LABEL WAS SENT TO THE DISTRIBUTOR WHO, IN TURN, FORWARDED IT TO THE CUSTOMER.THE INVESTIGATION EVALUATED WHETHER ANY OTHER PRODUCTS, APART FROM THE ADJUSTMENT SOCKET OF T0S0-01, HAD AN INCORRECT EXPIRY DATE. THE INVESTIGATION DETERMINED THAT ONLY ADJUSTMENT SOCKETS MANUFACTURED IN LOT 56016 BY ARTA PLAST WERE AFFECTED. AS STERILITY WAS CONFIRMED TO BE VALID FOR ALL DEVICES OF THE AFFECTED LOT 56016, NO HARM CAME TO ANY PATIENT, USER OR ENVIRONMENT. NO AFFECTED DEVICES OF THE AFFECTED LOT 56016 WERE INTENDED FOR, OR HAD BEEN PLACED ON, THE US MARKET. A REVIEW OF THE DATA FIELDS IN THE ORDER MANAGEMENT SYSTEM, IFIDELITY, IN WHICH LABELS ARE GENERATED, REVEALED THAT THE FIELD FOR THE EXPIRY DATE FOR ALL ORDERS ASSOCIATED WITH LOT 56016 WAS INCORRECTLY SET TO 0 MONTHS RATHER THAN 12 MONTHS. SINCE THIS VALUE WAS 0, THE MANUFACTURING DATE AND EXPIRY DATE BECAME THE SAME DATE, WHEREAS THE SYSTEM SHOULD HAVE ADDED 12 MONTHS TO THE MANUFACTURING DATE TO GENERATE THE CORRECT EXPIRY DATE. THE EXPIRY DATE PRINTED ON THE LABEL OF THE ADJUSTMENT SOCKET CONSTITUTES PART OF THE DEVICE'S LABELING UNDER 21 CFR PART 801. THE INCORRECT EXPIRY DATE PRINTED ON THE LABEL CONSTITUTES A FAILURE TO MEET THE DEVICE'S LABELING SPECIFICATIONS AND THEREFORE CONSTITUTES A MALFUNCTION UNDER 21 CFR 803.3(K). IF THE MALFUNCTION WERE TO RECUR AND THE DISCREPANCY COULD NOT BE RESOLVED PRIOR TO SURGERY, USE OF THE DEVICE COULD BE DELAYED WHILE THE EXPIRY DATE IS VERIFIED OR THE LABELING IS CORRECTED OR REPLACED. A DELAY IN TREATMENT COULD RESULT IN PROGRESSION OF THE UNDERLYING JOINT DAMAGE BEFORE SURGERY CAN BE COMPLETED. ALTHOUGH VERIFICATION, CORRECTION OR REPLACEMENT OF THE LABEL WOULD MOST LIKELY OCCUR WITHIN A FEW DAYS, IT CANNOT BE ENSURED THAT THE HEALTH CARE PROFESSIONAL, HEALTH CARE FACILITY, AND PATIENT WOULD BE AVAILABLE TO RESCHEDULE THE PROCEDURE WITHOUT SIGNIFICANT DELAY. THEREFORE, IT CANNOT BE RULED OUT THAT RECURRENCE OF THE MALFUNCTION COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY AS DEFINED IN 21 CFR 803.3(W).ROOT CAUSE INVESTIGATION BY THE MANUFACTURER DETERMINED THAT THE INSPECTION PROCESS LACKED AN ADEQUATE REVIEW CHECK IN THE ORDER REVIEW FORM (BATCH RECORD) TO VERIFY THAT THE CORRECT EXPIRY DATE WAS INCLUDED ON THE PRINTED LABEL. CORRECTIVE ACTIONS WERE IMPLEMENTED TO ADD EXPLICIT VERIFICATION OF THE EXPIRY DATE IN THE AFFECTED REVIEW AND RELEASE STEPS. THE REPORTED MALFUNCTION WAS DETERMINED TO BE APPLICABLE TO THE US-MARKETED EPISEALER PATELLOFEMORAL SYSTEM (PRODUCT CODE KRR), CLEARED UNDER FDA 510(K) K221048, DUE TO ITS SIMILARITY TO THE ADJUSTMENT SOCKET THAT IS NOT ON THE US MARKET. THEREFORE, THIS EVENT WAS ASSESSED FOR MDR REPORTABILITY BASED ON THE REASONABLY FORESEEABLE RECURRENCE OF THE MALFUNCTION IN THE CORRESPONDING US-MARKETED DEVICE.