INION FREEDOMPIN¿

Description of Event or Problem

71-YEAR-OLD FEMALE PATIENT WITH UNDERLYING DISEASES INCLUDING HYPERTENSION GRADE 2, TYPE 2 DIABETES MELLITUS, MILD ANAEMIA, SJÖGREN'S SYNDROME AND PERICARDIAL EFFUSION UNDERWENT INTERNAL FIXATION OPERATION OF A DISPLACED TRIMALLEOLAR ANKLE FRACTURE WITH TWO METAL HOLLOW SCREWS (UNKNOWN MANUFACTURER) AND ONE INION FREEDOMPIN (OPK-15K2, INION FREEDOMPIN¿ KIT Ø1.5 MM) IN (B)(6) 2025. THE PATIENT WAS DISCHARGED SUCCESSFULLY FROM THE HOSPITAL AFTER THE OPERATION. APPROXIMATELY 2 WEEKS LATER THE PATIENT WAS READMITTED TO HOSPITAL DUE TO POOR POSTOPERATIVE WOUND HEALING. DEBRIDEMENT AND REMOVAL OF METAL INTERNAL FIXATION WERE PERFORMED, THE INION FREEDOMPIN WAS LEFT IN PLACE. ACCORDING TO THE INFORMATION RECEIVED, NO BACTERIAL CULTURES WERE TAKEN FROM THE WOUND AND NO ANTIBIOTIC TREATMENT WAS GIVEN. THE WOUND HEALED AFTER DEBRIDEMENT AND METAL FIXATION REMOVAL. THE FRACTURE HAS BEEN HEALING WELL.

Additional Manufacturer Narrative

ACCORDING TO THE SURGEON, THE MOST PROBABLE CAUSE OF THE PATIENT'S IMPAIRED POSTOPERATIVE WOUND HEALING WAS RELATED TO PATIENT-RELATED FACTORS (UNDERLYING DISEASES) COMBINED WITH LONG SURGICAL TIME AND MASSIVE TRAUMA. PARTICULARLY TYPE 2 DIABETES MELLITUS, HYPERTENSION, ANAEMIA AND PERICARDIAL EFFUSION ARE ALL KNOWN TO COMPROMISE VASCULAR FUNCTION, IMMUNE RESPONSE, AND TISSUE REGENERATION. NO BACTERIAL INFECTION WAS CONFIRMED (NO CULTURES TAKEN) BUT THE PRESENCE OF THESE COMORBIDITIES PROVIDES A PLAUSIBLE EXPLANATION FOR DELAYED HEALING. THEREFORE, THE WOUND COMPLICATION IS CONSIDERED PREDOMINANTLY PATIENT-RELATED RATHER THAN DEVICE-RELATED. IN THE BATCH RECORD REVIEW, IT WAS VERIFIED THAT THERE WAS NO OTHER COMPLAINTS OR NONCONFORMITIES RELATED TO THE PRODUCT LOT. FINAL RELEASE DOCUMENTATION OF OPK-15K2 LOT 2411001 WAS REVIEWED. STERILIZATION DOSE AND DIMENSIONAL AND MECHANICAL PROPERTIES OF THE LOT WERE WITHIN THE SPECIFICATION AND PRODUCT PACKAGING WAS ACCORDING TO SPECIFICATION. THERE WAS NO CUSTOMER COMPLAINTS OR NONCONFORMITIES OF STERILITY ISSUES RELATED TO THE STERILIZATION LOT WHERE THE PRODUCT BELONGED. ALTHOUGH THERE IS NO IMPLICATION THAT INION FREEDOMPIN WAS CONTRIBUTED TO THE POOR WOUND HEALING, BASED ON THE FACTS THAT THE WOUND HEALED AFTER DEBRIDEMENT AND REMOVAL OF METAL IMPLANTS WHILE INION FREEDOMPIN WAS LEFT IN PLACE AND THAT THE SURGEON HAS ATTRIBUTED THE EVENT PRIMARILY TO PATIENT-RELATED FACTORS AND SURGICAL COMPLEXITY, THE EVENT INVOLVED A SERIOUS INJURY, DEFINED BY THE NEED FOR SURGICAL DEBRIDEMENT AND REMOVAL OF METAL INTERNAL FIXATION. BECAUSE INION FREEDOMPIN WAS PART OF THE FIXATION CONSTRUCT AND BECAUSE THE CONTRIBUTION OF THE INION FREEDOMPIN CANNOT BE DEFINITELY RULED OUT WITH THE INFORMATION AVAILABLE, THIS EVENT WILL BE REPORTED TO THE FDA TO ENSURE COMPLIANCE WITH THE REPORTING REQUIREMENTS.