Abstract：
OBJECTIVE: To study the mechanical properties related to the typical functional failure modes of non-absorbable suture anchor in clinical use, and to support product design, development and verification.
METHODS: By retrieving the database of relevant adverse events, the typical functional failure modes of non-absorbable suture anchor were summarized, and the influencing factors of functional failure were further analyzed by studying the mechanical properties related to functional failure. The publicly available test data was retrieved for verification and provided reference for the researchers.
RESULTS: The typical functional failure modes of non-absorbable suture anchor include anchor failure, suture failure, fix loosening, inserter failure, which are related to the mechanical properties of products, such as screw-in torque and break torque of screw-in anchors, insertion force of knock-in anchors, suture strength, pull-out force before and after system fatigue test and elongation of sutures after fatigue test.
CONCLUSIONS: Enterprises should pay attention to improving the mechanical performance level of products through material, structural design and the suture weaving process to ensure the safety and effectiveness of products.
METHODS: By retrieving the database of relevant adverse events, the typical functional failure modes of non-absorbable suture anchor were summarized, and the influencing factors of functional failure were further analyzed by studying the mechanical properties related to functional failure. The publicly available test data was retrieved for verification and provided reference for the researchers.
RESULTS: The typical functional failure modes of non-absorbable suture anchor include anchor failure, suture failure, fix loosening, inserter failure, which are related to the mechanical properties of products, such as screw-in torque and break torque of screw-in anchors, insertion force of knock-in anchors, suture strength, pull-out force before and after system fatigue test and elongation of sutures after fatigue test.
CONCLUSIONS: Enterprises should pay attention to improving the mechanical performance level of products through material, structural design and the suture weaving process to ensure the safety and effectiveness of products.
摘要：
目的：研究临床使用中与不可吸收缝线锚钉典型功能失效模式相关的机械性能，并支持产品设计，开发和验证。
方法：通过检索相关不良事件数据库，总结了不可吸收缝线锚钉的典型功能失效模式,通过研究与功能失效相关的力学性能,进一步分析了功能失效的影响因素。检索公开的测试数据进行验证，为研究人员提供参考。
结果：不可吸收缝线锚钉的典型功能失效模式包括锚钉失效，缝合失败,固定松动,插入器故障,这与产品的机械性能有关，如拧入扭矩和拧入锚的断裂扭矩，敲入锚的插入力，缝合强度,系统疲劳试验前后的拉脱力和疲劳试验后的缝合线伸长率。
结论：企业应注意通过材料提高产品的机械性能水平，结构设计和缝合编织工艺，确保产品的安全性和有效性。
方法：通过检索相关不良事件数据库，总结了不可吸收缝线锚钉的典型功能失效模式,通过研究与功能失效相关的力学性能,进一步分析了功能失效的影响因素。检索公开的测试数据进行验证，为研究人员提供参考。
结果：不可吸收缝线锚钉的典型功能失效模式包括锚钉失效，缝合失败,固定松动,插入器故障,这与产品的机械性能有关，如拧入扭矩和拧入锚的断裂扭矩，敲入锚的插入力，缝合强度,系统疲劳试验前后的拉脱力和疲劳试验后的缝合线伸长率。
结论：企业应注意通过材料提高产品的机械性能水平，结构设计和缝合编织工艺，确保产品的安全性和有效性。
