Device-related complications in hindfoot intramedullary nailing: A five-year analysis of the MAUDE database.

BACKGROUND

Intramedullary hindfoot nailing remains a valuable technique for deformity correction, trauma, and limb salvage in high-risk patients. Despite widespread use, limited post-market data exist characterizing device-related complications in real-world practice.

PURPOSE: This study examines device-related complications associated with hindfoot intramedullary nailing as reported in the FDA's Manufacturer and User Facility Device Experience (MAUDE) database.

STUDY

DESIGN

Descriptive epidemiologic database study.

METHODS

MAUDE reports from 2020-2024 related to hindfoot intramedullary nailing were reviewed, screened, and de-duplicated. Events were categorized by primary complication type. Descriptive statistics summarized complication patterns. Chi-square analysis compared mechanical versus biological complications, and linear regression assessed temporal reporting trends.

RESULTS

Of 426 identified reports, 144 unique events met inclusion criteria. Mechanical complications accounted for 68.1% (n = 98), while biological or patient-driven complications comprised 31.9% (n = 46) (p < 0.001). The most frequent mechanical events involved targeting guide or jig failure (25.0%), nail body failure (18.8%), and screw-related failure (16.0%). Biological complications most commonly included hardware pain (10.4%), infection or wound-related events (9.7%), and nonunion (9.0%). Reporting peaked in 2021, declined in 2022, and rebounded modestly in 2023-2024, with no significant linear trend (p = 0.81).

CONCLUSION

Most reported complications were mechanical and often reflect expected intraoperative challenges inherent to complex hindfoot reconstruction. Nonetheless, true device failures remain clinically meaningful, highlighting the need for meticulous technique, continued implant refinement, and robust post-market surveillance to optimize patient safety.