PICCOLO COMPOSITE PROXIMAL FEMUR NAILING SYSTEM (NAIL)

Additional Manufacturer Narrative

EXAMINATION OF THE PRODUCTION RECORDS OF THE INVOLVED NAIL DID NOT REVEAL ANY DEVIATION FROM SPECIFICATION. THE EXPLANTED NAIL (NOR THE CASE X-RAYS) WAS NOT AVAILABLE TO THE MANUFACTURER; THEREFORE, NAIL PHYSICAL EXAMINATION WAS NOT FEASIBLE. ALTHOUGH THE NAIL COULD NOT BE EXAMINED, THE FACT THAT IT FRACTURED AFTER FIVE MONTHS IN METASTATIC BONE WITH NON-UNION SUGGESTS A FATIGUE FRACTURE. BREAKAGE OF PROXIMAL FEMUR NAILS IS KNOWN AND DOCUMENTED IN THE LITERATURE, WITH REPORTED RATES THAT RANGE FROM 0.2% TO 5.6%. THE RISK OF IMPLANT FAILURE INCREASES IN CASE OF PATHOLOGICAL FRACTURES, AS IN THE DESCRIBED CASE. [1] THE COMPANY IS ACTIVELY SEEKING FOR MORE DATA. [1] JOHNSON NA ET AL., RISK FACTORS FOR INTRAMEDULLARY NAIL BREAKAGE IN PROXIMAL FEMORAL FRACTURES: A 10-YEAR RETROSPECTIVE REVIEW. ANN R COLL SURG ENGL. 2017; 99(2): 145-150.

Description of Event or Problem

ON MARCH 16, 2026, THE COMPANY BECAME AWARE OF A CASE INVOLVING ITS PICCOLO COMPOSITE PF NAIL. BASED ON THE INFORMATION PROVIDED TO THE COMPANY, THE DEVICE WAS IMPLANTED IN AN ONCOLOGIC PATIENT WITH FEMORAL METASTASES ON (B)(6) 2024, FOLLOWING A FALL RESULTING IN A PATHOLOGICAL FRACTURE OF THE FEMUR. APPROXIMATELY FIVE MONTHS POST-IMPLANTATION, THE NAIL FRACTURED AT OR NEAR THE LAG SCREW INTERFACE DUE TO NON-UNION. ON (B)(6) 2025, THE NAIL WAS REMOVED AND REPLACED WITH A TOTAL HIP PROSTHESIS.