全内半月板修复系统失效分析显示器械相关不良事件因器械设计类型而异且制造商报告延迟各异
简介
基于美国FDA不良事件数据库，对2023—2024年全内侧半月板修复装置的2056例故障报告进行了回顾性队列分析。结果显示，最常见的装置故障为装置脱离（20.76%）、击发失败（20.21%）和装置断裂（15.46%），且不同设计类型的失效模式存在显著差异：全缝合锚钉以断裂为主（41.6%），刚性囊结锚钉特异性出现器械间不兼容，而刚性半月板结锚钉则以击发和同…
英文摘要
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.