A Study of Adverse Events Associated with Endodontic Files Utilizing the Manufacturer and User Facility Device Experience (MAUDE) Database

Background: Endodontic treatment relies on instrumentation to effectively disinfect and seal the root canal system. Nickel-Titanium (NiTi) rotary files have improved efficiency and precision but remain susceptible to unexpected fractures, raising concerns regarding patient safety and treatment prognosis. Understanding the nature and frequency of adverse events associated with these files is essential for improving clinical practice. The objective of our study is to investigate and characterize adverse events linked to endodontic rotary files, utilizing the US Food and Drug Administration’s Manufacturer and User Facility Device Experience (MAUDE) database for the years 2023 and 2024. Methods: A retrospective study was performed using the MAUDE database. Reports from 2023 and 2024 were identified using the keywords “endodontic file” and “breakage.” Relevant reports were categorized by device- and patient-related issues, including device malfunctions, injuries, embedded files and other harms. Data extraction and categorization were conducted by two independent reviewers. Descriptive statistics were used for quantitative analysis and qualitative methods for identifying recurring risk factors. Study limitations due to underreporting and incomplete records in the MAUDE database were acknowledged. Results: Device malfunctions were the predominant adverse event, with file breakage accounting for 313 reports in 2024, an increase from 260 in 2023. Patient complications primarily involved files becoming embedded in tissue (237 reports in 2024; 197 in 2023). Total reported incidents were 595 in 2023 and 656 in 2024, with a nearly equal distribution between device- and patient-related issues. Retrieval rates of broken files were low (29 in 2023; 22 in 2024) and device evaluation by manufacturers occurred in 264 cases, while only 91 devices were available for assessment. Incomplete or inconclusive clinical information was noted in a subset of reports. Conclusion: File breakage remains the most common and clinically significant adverse event associated with endodontic files, with device durability and retrieval challenges affecting patient outcomes. Both device characteristics and patient-specific factors contribute substantially to the occurrence of adverse events. The study underscores the need for improved manufacturing processes, refined clinical techniques and enhanced reporting systems to minimize risks. Future research should target innovations in file design, technique and incident reporting to ensure safer and more reliable endodontic practice.