Case Report

How Shall We Proceed After Inserting an Unsterile Device for Fracture Fixation: ReTENing or Retaining? A Case Report

Abstract

Background: Limited information is available on how to properly manage to implant nonsterile devices in the medical literature. To the best of our knowledge, there is no guideline for managing nonsterile medical devices implanted inadvertently. 

Case Presentation: A 3.5-year-old boy was operated on because of femur fracture malunion. After the completion of the operation and discharging the patient, we were informed that the nail has not been sterilized. The parents were immediately informed about the complication and the patient was re-admitted to the hospital. The situation and its complication were thoroughly discussed with the family. By active involvement of the parents, infectious specialist, and the orthopedic surgeon, a shared decision was made to treat the complication. The patient was closely observed. In a radiograph obtained at the 4th week after the index surgery, the sign of callus formation was observed. At this time, we decided to remove the Titanium Elastic Nail (TEN) and continue casting for another two weeks.

Conclusion: The primary “take-away” lesson of this case report is that honest disclosure of our mistake facilitated the additional necessary treatment. One single case is not enough for making a recommendation or offer a guideline for this kind of error during or after an orthopedic procedure; however, this case presents a successful method. Although the consequences of infection could be dire, it is prudent to take “not-to-harm” as the first step in benefiting.

[1] Bell SK, Man KJ, Troug R, Latos JD. Should we tell parents when we’ve made an error? Pediatrics. 2015; 135(1):159-63. [DOI:10.1542/peds.2014-0293] [PMID]
[2] Jarman H, Rozenblum S, Huang TJ. Neither protective nor harmonized: The crossborder regulation of medical devices in the EU. Health Economics, Policy and Law. 2021; 16(1):51-63. https://www. cambridge.org/core/journals/health-economics
[3] Khan A, Furtak SL, Melvin P, Rogers JE, Schuster MA, Landrigan CP. Parent-reported errors and adverse events in hospitalized children. JAMA Pediatrics. 2016; 170(4):e154608. [DOI:10.1001/jamapediatrics.2015.4608] [PMID] [PMCID]
[4] Starr P. The social transformation of American medicine [PHd. dissertation]. Harvard: Harvard University; 1982.
[5] Institute of Medicine (US) Committee on Quality of Health Care in America, Kohn LT, Corrigan JM, Donaldson MS. To err is human: Building a safer health system. Washington (DC): The National Academies Press (US); 2000. [DOI:10.17226/9728] [PMID]
[6] Brennan TA. The institute of medicine report on medical errorscould it do harm? The New England Journal of Medicine. 2000; 342(15):1123-5. [DOI:10.1056/NEJM200004133421510] [PMID]
[7] Hayward RA, Hofer TP. Estimating hospital deaths due to medical errors: Preventability is in the eye of the reviewer. The Journal of the American Medical Association. 2001; 286(4):415-20. [DOI:10.1001/ jama.286.4.415] [PMID]
[8] McDonald CJ, Weiner M, Hui SL. Deaths due to medical errors are exaggerated in institute of medicine report. The Journal of the American Medical Association. 2000; 284(1):93-5. [DOI:10.1001/ jama.284.1.93] [PMID]
[9] Vautrin M, Moerenhout K, Udin G, Borens O. Perioperative contamination of orthopaedic polyethylene implants, targeting devices and arthroscopes. Experts’ decision tree and literature review. Journal of Bone and Joint Infection. 2019; 4(2):65-71. [DOI:10.7150/ jbji.30613] [PMID] [PMCID]
[10] Centers for Disease Control (CDC). Postsurgical infections associated with nonsterile implantable devices. Morbidity and Mortality Weekly Report (MMWR). 1992; 41(15):263. [PMID]
[11] Gosselin RA, Spiegel DA, Foltz M. Global orthopedics: Caring for musculoskeletal conditions and injuries in austere settings. Cham: Springer; 2019 [DOI:10.1007/978-3-030-13290-3]
[12] Cornell RS, Hood CR. What you should know about biofilm and implants. Podiatry Today. 2015; 28(8):38-46. https://www.podiatrytoday.com/what-you-should-know-about-biofilm-and-implants
[13] Werner CML, Necas T, Schneeberger AG. Defects of camera covers after arthroscopic surgery. Journal of Shoulder and Elbow Surgery. 2006; 15(2):199-202. [DOI:10.1016/j.jse.2005.08.016] [PMID]
[14] Andrade N, Schmiedt CW, Cornell K, Radlinsky MG, Heidingsfelder L, Clarke K, er al. Survey of intraoperative bacterial contamination in dogs undergoing elective orthopedic surgery. Veterinary Surgery. 2016; 45(2): 214-22. [DOI:10.1111/vsu.12438] [PMID]
Files
IssueVol 6 No 2 (2021): Mar/Apr QRcode
SectionCase Report(s)
Published2021-08-07
DOI https://doi.org/10.18502/crcp.v6i2.6686
Keywords
Device Infection Case report Orthopedic surgery Shared decision

Rights and permissions
Creative Commons License This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
How to Cite
1.
Zargarbashi R, Panjavi B, Bozorgmanesh M. How Shall We Proceed After Inserting an Unsterile Device for Fracture Fixation: ReTENing or Retaining? A Case Report. CRCP. 2021;6(2):51-54.