EPISEALER FEMORAL TWIN

Description of Event or Problem

ON THE 24TH OF MARCH 2025 AT 12:03 (UTC+01:00), THE DISTRIBUTOR IN POLAND CONTACTED THE MANUFACTURER, EPISURF OPERATIONS AB, REGARDING A DISCREPANCY BETWEEN CASE ID (b)(4) WHICH WAS SPECIFIED ON THE IMPLANT, INSTRUMENTS, AND ORDER HANDLING SYSTEM AND CASE ID (b)(4), WHICH WAS SPECIFIED IN THE FINAL DESIGN DOCUMENT. THE CASE ID IS AN ORDER NUMBER SPECIFIC TO A PATIENT'S SURGICAL PROCEDURE. THE FINAL DESIGN DOCUMENT IS SUPPLIED WITH THE DEVICE AND PROVIDES INFORMATION REGARDING POSITIONING OF A GUIDE INSTRUMENT FOR IMPLANT PLACEMENT. THE EVENT INVOLVED AN EPISEALER FEMORAL TWIN DEVICE THAT IS NOT MARKETED IN THE UNITED STATES (US). ON THE 24TH OF MARCH 2025 AT 13:03 (UTC+01:00), THE MANUFACTURER CONFIRMED THAT THE CASE ID IN THE TEXT FIELD OF THE FINAL DESIGN DOCUMENT WAS INCORRECTLY SPECIFIED AS (b)(4). AN INVESTIGATION WAS PERFORMED BY REVIEWING THE CASE ID SPECIFIED ON THE IMPLANT AND INSTRUMENTS LABELING, THE CASE ID SPECIFIED IN THE ORDER HANDLING SYSTEM AND THE CASE ID SPECIFIED IN THE FINAL DESIGN DOCUMENT FOR CASE (b)(4). THE INVESTIGATION CONCLUDED THAT THE INCORRECT CASE ID WAS LIMITED TO THE TEXT FIELD IN THE FINAL DESIGN DOCUMENT. ALL OTHER INFORMATION IN THE FINAL DESIGN DOCUMENT WAS CORRECT, INCLUDING AN IMAGE DISPLAYING CASE ID (b)(4), WHICH CORRESPONDED WITH THE CASE ID ON THE IMPLANT, PATIENT-SPECIFIC INSTRUMENTS, AND PRODUCT LABELS, THEREBY CONFIRMING THAT THE FINAL DESIGN DOCUMENT WAS INTENDED FOR THE CORRECT PATIENT AND PROCEDURE.THE DISTRIBUTOR AND SURGEON REVIEWED THE INFORMATION AND PROCEEDED WITH THE SURGICAL PROCEDURE AFTER CONFIRMING THAT THE IMAGE WITHIN THE FINAL DESIGN DOCUMENT CORRESPONDED TO THE INTENDED SURGICAL PROCEDURE FOR THE INTENDED PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THE DISTRIBUTOR CONFIRMED THAT NO INJURY TO THE PATIENT, USER, OR ENVIRONMENT OCCURRED.THE MANUFACTURER DETERMINED THAT THE INCORRECT CASE ID IN THE FINAL DESIGN DOCUMENT CONSTITUTES A MALFUNCTION UNDER 21 CFR 803.3 BECAUSE THE FINAL DESIGN DOCUMENT IS A LABELING COMPONENT OF THE DEVICE THAT FAILED TO CORRECTLY IDENTIFY THE DEVICE. IF THIS MALFUNCTION WERE TO RECUR AND THE DISCREPANCY COULD NOT BE RESOLVED PRIOR TO SURGERY, USE OF THE DEVICE COULD BE DELAYED WHILE THE DEVICE IDENTITY 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 FINAL DESIGN DOCUMENT WOULD MOST LIKELY OCCUR WITHIN A FEW DAYS, IT CANNOT BE ENSURED THAT THE HEALTH CARE PROFESSIONAL, HEALTHCARE 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 SERIOUS INJURY AS DEFINED IN 21 CFR 803.3(W). ROOT CAUSE INVESTIGATION BY THE MANUFACTURER DETERMINED THAT THE INSPECTION PROCESS DID NOT EXPLICITLY REQUIRE VERIFICATION OF THE CASE ID AFTER GENERATION OF THE FINAL DESIGN DOCUMENT AND DID NOT INCLUDE VERIFICATION OF THE CASE ID DURING PRINTING AND PACKAGING ACTIVITIES DOCUMENTED IN THE ORDER REVIEW FORM (BATCH RECORD). CORRECTIVE ACTIONS WERE IMPLEMENTED TO ADD EXPLICIT VERIFICATION OF THE CASE ID IN THE AFFECTED REVIEW AND RELEASE STEPS. THE REPORTED MALFUNCTION WAS DETERMINED TO ALSO BE APPLICABLE TO THE US-MARKETED EPISEALER PATELLOFEMORAL SYSTEM (PRODUCT CODE KRR), CLEARED UNDER FDA 510(K) K221048, DUE TO ITS SIMILARITY TO THE EPISEALER FEMORAL TWIN. THEREFORE, THIS EVENT WAS ASSESSED FOR MDR REPORTABILITY BASED ON THE REASONABLY FORESEEABLE RECURRENCE OF THE MALFUNCTION IN THE CORRESPONDING US-MARKETED DEVICE.