All-Inside Meniscus Repair Systems Failure Analysis Shows Device-Related Adverse Events Differ by Device Design Type and Show Varied Reporting Delays by Manufacturer.

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.