Study of Typical Functional Failure and Mechanical Properties of Non-absorbable Suture Anchor.
10.3969/j.issn.1671-7104.2023.03.003
- Author:
Jintao GAO
1
;
Zhen ZHEN
2
;
Dan HAN
1
;
Bin LIU
1
Author Information
1. GBA Center for Medical Device Evaluation and Inspection, NMPA, Shenzhen,
2. Center for Medical Device Evaluation, NMPA, Beijing,
- Publication Type:Journal Article
- Keywords:
functional failure;
mechanical properties;
sport medicine;
suture anchor
- MeSH:
Suture Anchors;
Suture Techniques;
Sutures;
Absorbable Implants;
Biomechanical Phenomena;
Materials Testing
- From:
Chinese Journal of Medical Instrumentation
2023;47(3):247-251
- CountryChina
- Language:Chinese
-
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.
