ALLAY NERVE CAP

Description of Event or Problem

ON (B)(6) 2025, A PATIENT UNDERWENT A LEFT ANKLE ARTHROSCOPY AND NEURECTOMY OF THE SAPHENOUS NERVE. THE TERMINAL END OF THE NERVE WAS CAPPED WITH THE ALLAY NERVE CAP. APPROXIMATELY 8 WEEKS AFTER THE PROCEDURE (B)(6) 2026), THE PATIENT REPORTED A GEL-LIKE MATERIAL APPEARING THROUGH TWO PINPOINT OPENINGS FROM THE PROXIMAL INCISION SITE. THE PATIENT STATED SHE HAD STARTED PHYSICAL THERAPY THE DAY BEFORE; SHE STATED THE PAIN SHE WAS EXPERIENCING PRIOR TO THE SURGERY HAD IMPROVED. PRESSURE WAS APPLIED TO THE INCISION SITE AND THE CLINIC STATED APPROXIMATELY 0.5-1CC OF HYDROGEL WAS REMOVED. AT THE TIME, IT WAS NOTED THAT NO NEUROMA HAD FORMED AND PREVIOUS SENSITIVITY AND TINEL'S SIGN WAS ABSENT FROM THE AREA. HOWEVER, MILD PAIN WAS NOTED ON PALPATION TO THE INCISION SITE. ON (B)(6) 2026, THE PATIENT UNDERWENT A REVISION SURGERY WHERE SCAR TISSUE WAS NOTED SURROUNDING THE SAPHENOUS NERVE AND A STUMP NEUROMA WAS IDENTIFIED AT THE PREVIOUS SURGICAL SITE. THE ALLAY NERVE CAP WAS IDENTIFIED AND REMOVED FROM THE SURGICAL SITE. THE WOUND SITE WAS FLUSHED WITH STERILE NORMAL SALINE AND NO REMAINING HYDROGEL MATERIAL WAS IDENTIFIED PRIOR TO CLOSURE. THE STUMP NEUROMA WAS THEN RESECTED TO A HEALTHY BLEEDING NERVE STUMP AND A NERVE CONDUIT WAS UTILIZED TO CAP THE NERVE. LOT HISTORY RECORD REVIEW CONFIRMED THE PRODUCT LOT MET ALL PRODUCT SPECIFICATIONS, WITH NO QUALITY ISSUES IDENTIFIED. THE HYDROGEL MAY HAVE BEEN PLACED DIRECTLY UNDER THE SUTURE CLOSURE LINE WHICH ALLOWED IT TO BE INADVERTENTLY EXPELLED. THE PATIENT'S LONGSTANDING HISTORY OF SMOKING (TOBACCO) AND PHYSICAL THERAPY LIKELY CONTRIBUTED TO THE WOUND DEHISCENCE. THE INSTRUCTIONS FOR USE STATES THE SURGICAL SITE SHOULD BE CLOSED IN LAYERS WHICH MAY NOT HAVE BEEN DONE IN THIS CASE. THE PHYSICIAN HAS BEEN INFORMED OF BEST PRACTICES PER THE INSTRUCTIONS FOR USE WHEN USING THE ALLAY NERVE CAP. NO FURTHER ACTION IS REQUIRED. THERE IS NO EVIDENCE OF DEVICE MALFUNCTION, AND THE EVENT IS CONSIDERED PRIMARILY ATTRIBUTABLE TO PATIENT, PROCEDURAL, AND POST-OPERATIVE FACTORS.

Additional Manufacturer Narrative

THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION; THEREFORE, NO DEVICE EVALUATION COULD BE PERFORMED. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE.