Safety Profile of a Novel Open-Platform Handheld Robotic System: A MAUDE Database Analysis of TMINI Adverse Events.

Document Type

Conference Proceeding - Restricted Access

Publication Date

5-8-2026

Abstract

Handheld robotic systems for Total Knee Arthroplasty (TKA), such as the TMINI Miniature Robotic System, aim to provide the precision and accuracy of a robotically performed TKA (rTKA) while addressing the usability challenges of previous rTKA systems. As a novel open platform system, its performance and safety profile remain poorly described. Post-market surveillance is critical for identifying early technical challenges that may not be evident in the developing phase of the system. This study analyzed adverse event reports to characterize the etiology, and clinical impact of adverse events associated with this novel device to inform surgeons of possible issues that could arise with its use.

A retrospective review of the FDA Manufacturer and User Facility Device Experience (MAUDE) database for all reports involving the TMINI system from its initial FDA approval through December 2025 was conducted. Initially, 22 reports were retrieved. After removing duplicate reports and excluding M.U.S.T Mini cases captured due to the name similarity, a final data set of 17 adverse events was identified. The adverse events were categorized into four types: Mechanical/Hardware, Software/User interface, Precision/Accuracy, and User/Procedural issues. Descriptive statistics were used to determine the frequency of each occurrence type within the overall complication numbers captured.

A total of 17 adverse events were identified. Mechanical/Hardware malfunction were the most common challenges (47.1%, n=8), characterized by component detachment and drill trigger malfunctions. User/Procedural errors (23.5%, n=4) were associated with poor bone quality impacting pin fixation or unauthorized manual manipulation of tracking arrays. Precision/Accuracy deviations (17.6%, n=3) showed the only intraoperative conversion to manual instrumentation due to a 3.4° varus alignment error and instances of femoral notching. Software/Interface anomalies (11.8%, n=2) involved display and data synchronization failures. No permanent patient harm was reported.

Mechanical/Hardware issues, specifically regarding component integrity, represented the most common category of adverse events reported for this novel handheld robotic system. The reports of component detachment suggest the need for a standardized preoperative hardware inspection protocol. Early review of complications suggests that system accuracy is clinically acceptable but remains sensitive to user technique and fixation stability, particularly in osteopenic bone.

Comments

2026 Research Day Corewell Health West, Grand Rapids, MI, May 8, 2026. Abstract 1943

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