Abstract: Objective To investigate the effect of root cause analysis on cleaning and sterilization effect of orthopedic implant devices and postoperative infection of patients. Methods A total of 524 patients undergoing orthopaedic surgery treated in the Zhejiang Zhuji People's Hospital from May 2017 to May 2019 were selected. The patients were treated with orthopaedic implant machine, according to the time order were divided into two groups, control group, 260 cases of patients with for our patients before returning for analysis, 264 patients with the team for our patients after the implementation of returning for analysis, analysis in the implementation of returning for analysis before and after the orthopaedic implant machine clean and sterilization condition, and infections in patients with conditions for record. Results A total of 524 patients were included in this study, among which 46 were infected, 63 strains were detected, among which 41 strains were gram-positive bacteria, accounting for 65.1%. Staphylococcus aureus(18 strains, accounting for 28.6%) was the largest among gram-positive bacteria, and pseudomonas aeruginosa(9 strains, accounting for 14.3%) was the largest among gram-negative bacteria. The incidence of besmirch instrument, rusty instrument and backwash instrument in the research group was all higher than that in the control group(all P<0.05), and the total qualified instrument rate in the research group was higher than that in the control group(P<0.05). The infection rate of the study group was 6.8%, and that of the control group was 15.8%. The infection rate of the study group was lower than that of the control group(P<0.05). Conclusion In patients with orthopedic infection, the main infection strains are gram-positive bacteria. In the treatment of surgical instrument implantation, the use of root cause analysis method to evaluate the sterilization quality of the instrument can effectively improve the cleaning and sterilization quality of orthopedic instrument implantation, and reduce the postoperative infection rate of patients. It can be further popularized and applied in clinic.