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All-Inside Meniscus Repair Systems Failure Analysis Shows Device-Related Adverse Events Differ by Device Design Type
Tzadok Yona1, Bhavya Sheth2, Noam Reshef3,4
1Gray Faculty of Medical & Health Sciences, Tel-Aviv University, Tel Aviv, Israel.
Purpose:
To investigate common failures of all-inside meniscal repair devices and associated patient injuries and determine whether specific device designs show distinct patterns of adverse events.
Methods:
The Food and Drug Administration's Manufacturer and User Facility Device Experience database was queried for adverse events involving all-inside meniscal repair devices from 2023 to 2024. Data collected included device problems, patient injuries, manufacturer details, and time to report incidents. Device problems were categorized into 11 groups: Detachment of Device or Device Component, Failure to Fire, Fracture, Device-Device Incompatibility, Simultaneous Fire, Premature Activation, Physical Resistance/Sticking, Manufacturing, Packaging or Shipping Problem, Sutures Torn, Material Deformation, and Separation Failure. Statistical analyses included frequency counts, percentages, and Kruskal-Wallis test, with significance at P < .05.
Results:
Three thousand fifty-six device malfunctions were reported in 2023 to 2024. After excluding 8 nonmeniscal repair devices, 908 duplicates and 84 reports lacking sufficient information, 2056 eligible reports were analyzed. Among these, 114 associated patient injuries (5.5%). The most frequent device problems were Device Detachment (486, 20.76%), Failure to Fire (473, 20.21%), Device Fracture (362, 15.46%), and Device-Device Incompatibility (346, 14.78%). Reporting delays varied significantly by manufacturer, ranging from a median of 13 to 33.5 days (P < .001). Reported device problems varied significantly by design group (P < .001). All-suture anchors showed the highest rate of Device Fracture (101, 41.6%), whereas rigid capsular-knot anchors were uniquely associated with Device-Device Incompatibility (346, 34.0%). Rigid meniscal-knot anchors predominantly failed due to deployment errors, most notably "Failure to Fire" (391, 36.2%) and "Simultaneous Fire" (215, 19.9%).
Conclusions:
Adverse event causes differed by system design. All-suture anchors most frequently failed by Fracture of the device, rigid anchors with a capsular knot showed a unique susceptibility to Device-Device Incompatibility, and rigid anchors with a meniscal knot were primarily associated with deployment-related errors.
Level Of Evidence:
Level IV, retrospective comparative cohort.