ALLAY NERVE CAP

Description of Event or Problem

ON (B)(6) 2025, A PATIENT WITH A HISTORY OF PRIOR NEUROMA FORMATION UNDERWENT A REVISION NEURECTOMY WHERE PRIOR COLLAGEN CONDUITS AND ASSOCIATED NEUROMAS WERE EXCISED. THE ALLAY NERVE CAP WAS APPLIED TO THE TERMINAL ENDS OF THE MEDIAN AND ULNAR NERVES. THE SURGEON PERFORMED TWO ITERATIONS OF THE CAP APPLICATION ON THE ULNAR NERVE TO ENSURE FULL CIRCUMFERENTIAL COVERAGE WHILE THE MEDIAN NERVE WAS COVERED WITH ONE ITERATION. THE CAPPED MEDIAN NERVE WAS PLACED BENEATH THE MUSCLE LAYER AT THE CONCLUSION OF THE PROCEDURE. DUE TO THE LOW VOLUME OF SUBCUTANEOUS TISSUE, THE CAPPED ULNAR NERVE RESTED DIRECTLY BENEATH THE SKIN. APPROXIMATELY 10 MONTHS AFTER THE REVISION NEURECTOMY AND CAPPING PROCEDURE, THE PATIENT PRESENTED WITH A PALPABLE LUMP AT THE UPPER MEDIAL ASPECT OF HIS ARM WITH SYMPTOMS INDICATING SYMPTOMATIC NEUROMA. ON (B)(6) 2026, A SITE EXPLORATION FOR REVISION WAS PERFORMED. UPON EXPLORATION OF THE SURGICAL SITE, THE SURGEON IDENTIFIED SMALL PIECES OF HYDROGEL AT A DIRECTLY SUPERFICIAL LEVEL AND A NEUROMA AT THE TERMINAL END OF THE ULNAR NERVE. THE HYDROGEL WAS SUBSEQUENTLY REMOVED AND A DIFFERENT NERVE CAP WAS PLACED ON THE NERVE. THE MEDIAN NERVE WAS NOT RE-EXPLORED BUT APPEARED CLINICALLY UNREMARKABLE AND WAS ASYMPTOMATIC. THERE WERE NO SIGNS OF INFECTION OR LOCAL REACTION. THE SURGEON NOTED THAT THE HYDROGEL CAP HAD LIKELY BEEN MANIPULATED BY THE PATIENT AND CONTRIBUTED TO THE RESULT. LOT HISTORY RECORD REVIEW CONFIRMED THE PRODUCT LOT MET ALL PRODUCT SPECIFICATIONS, WITH NO QUALITY ISSUES IDENTIFIED. THE HYDROGEL WAS PLACED DIRECTLY UNDER THE SUTURE CLOSURE LINE WHICH ALLOWED IT TO BE INADVERTENTLY MANIPULATED. THE PATIENT'S IV DRUG USE MAY HAVE FURTHER EXACERBATED 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 SURGEON 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. THIS REPORT IS SUBMITTED MORE THAN 30 DAYS AFTER THE AWARE DATE. TO ADDRESS THIS ISSUE, CAPA-0024 HAS BEEN OPENED TO INVESTIGATE AND IMPLEMENT APPROPRIATE ACTIONS.