AXOGUARD HA+ NERVE PROTECTOR

Description of Event or Problem

ON (B)(6) 2025, FEMALE PATIENT UNDERWENT CARPAL TUNNEL REVISION SURGERY. AT THE ONE-WEEK POST-OP APPOINTMENT, PATIENT HAD REDNESS AT THE INCISION SITE. SURGEON PUT PATIENT ON A FEW DAYS OF DOXYCYCLINE. AT THE TWO-WEEK POST-OP APPOINTMENT, PATIENT HAD WORSENING REDNESS AND PAIN AT THE SITE. SURGEON TOOK PATIENT BACK TO THE OR, IRRIGATED THE SITE, AND NOTICED THE HA+ PROTECTOR LOOKED LIKE A PIECE OF FATTY COLLAGEN. THE HA+ PROTECTOR WAS EXPLANTED AND FELL APART IN TWO PIECES. THE SURGEON HAD CULTURES SENT WHICH WERE NEGATIVE FOR INFECTION, DID NOT SEND FOR PATHOLOGY. SINCE THE HA+ PROTECTOR WAS EXPLANTED, EVENTS HAVE RESOLVED. NO CAUSALITY WAS REPORTED, THOUGH THE SURGEON REMARKED THAT THE PATIENT MAY HAVE NOT TOLERATED THE DEVICE. AXOGEN ASSESSED CAUSALITY AS POSSIBLY RELATED. CULTURES OBTAINED DURING EVALUATION WERE NEGATIVE, AND NO PATHOLOGY WAS PERFORMED, LIMITING THE ABILITY TO DETERMINE THE UNDERLYING CAUSE OF THE REPORTED REDNESS AND PAIN.

Additional Manufacturer Narrative

RECALL REPORT PULLED 27JAN2026 FOUND THAT 7 PRODUCTS FROM THE SAME LOT HAD SHIPPED AND 3 ARE LABELED AS FINISHED GOODS. THE DEVICE UTILIZATION REPORT PULLED 27JAN2026 FOUND NO PRODUCTS FROM THIS LOT THAT HAVE YET BEEN REPORTED IMPLANTED. THE DEVICE HISTORY RECORD REVIEW MEMO PROVIDED BY EVERGEN STATED: A REVIEW OF THE DEVICE LOT HISTORY RECORD INDICATED THE DEVICE WAS MANUFACTURED TO SPECIFICATIONS. THE NONCONFORMANCE WOULD NOT LIKELY CONTRIBUTE TO THE OCCURRENCE. THE LOT PRODUCED 10 DEVICES. ACCORDING TO THE DEVICE LOT HISTORY RECORD, ALL DEVICES RELEASED FOR DISTRIBUTION MET THE FINAL INSPECTION SPECIFICATION REQUIREMENTS AND STERILIZATION REQUIREMENTS.