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Revista de la Asociación Argentina de Ortopedia y Traumatología
On-line version ISSN 1852-7434
Abstract
RICCIARDI, Guillermo A et al. Lo que no te contaron de las fracturas de fémur. Rev. Asoc. Argent. Ortop. Traumatol. [online]. 2016, vol.81, n.2, pp.99-109. ISSN 1852-7434.
Background: This paper intends to correlate data obtained from different orthopedic surgical teams and literature on faulty instrumentation during femoral fracture treatment with intramedullary nailing. Objectives: 1) To define technical problems arising during surgical procedures to treat femoral fractures; 2) to compare different centers and problems; 3) to analyze possible ways to find a solution. Methods: 1) A retrospective, descriptive, observational study on clinical records and radiologic files was performed; 2) an on-line survey was sent to orthopedic surgeons; 3) a query was sent to ANMAT, IRAM, and Ministerios de Salud de la Ciudad Autónoma de Buenos Aires y de la Nación. Results: 1) 31 intramedullary femoral nailing procedures were performed from January 2008 to August 2013. Eighteen cases of surgical tool deficiencies in 14 patients. More frequent problems were related to drill bits and guide wires; 2) 270 forms were filled up, from 19 provinces of Argentina, and from Colombia, Ecuador, Italy, Australia and Bolivia. We received answers from 180 private institutions and 90 public hospitals; 3) there are four possible ways to reach a solution: ANMAT with its Programa de Tecnovigilancia, IRAM for non-fulfillment of ISO 9001 rules, Ministerios de Salud for nonfulfillment of resolution 255 and Ley Básica de Salud N.º 153, art. 12, items k and l, and AAOT Implants Subcommittee. Conclusions: A clear-cut difference was established between public and private centers; however, the working place only defined the prevalence of technical problems, but problems themselves were the same. There are legal and administrative tools to deal with these problems.
Keywords : Femur; Fracture; Complications; Surgical tools; Nail; Claim.