D Kluess1, K Zenk, W Mittelmeier. 1. Forschungslabor für Biomechanik und Implantattechnologie, Orthopädische Klinik und Poliklinik, Universitätsmedizin Rostock, Doberaner Str. 142, 18057, Rostock, Deutschland, daniel.kluess@med.uni-rostock.de.
Abstract
BACKGROUND: Breakage of instruments in orthopedic surgery is rarely reported but the consequences can be serious for both patients and surgeons. The medical device directive classifies instruments, such as drills and saws into risk class 1 with low approval requirements. Also the number of applications of reusable instruments is not currently limited. OBJECTIVES: The aim of this study was determine to what extent instrument failure can lead to reportable incidents and how these incidents should be processed. METHODS: The study involved an evaluation of clinical cases from our institution with a selective literature review and discussion of the medical device directive. RESULTS: The experience in our clinic showed that especially breakage of rasps in total hip and knee replacement surgery is associated with a major time extension of the operational procedure, a wider surgical access opening as well as complicated procedures to recover the fragments from the incident site. In individual cases a fenestration of the bone had to be conducted in order to collect the broken piece of the rasp. In one case a revision hip stem had to be used instead of the planned primary stem in order to bridge the fenestration site. CONCLUSION: Such consequences of instrument failure were considered to be a reportable incident. A thorough documentation as well as incident reporting to the manufacturer and the Federal authorities are required for a sufficient processing and risk assessment of the incident.
BACKGROUND: Breakage of instruments in orthopedic surgery is rarely reported but the consequences can be serious for both patients and surgeons. The medical device directive classifies instruments, such as drills and saws into risk class 1 with low approval requirements. Also the number of applications of reusable instruments is not currently limited. OBJECTIVES: The aim of this study was determine to what extent instrument failure can lead to reportable incidents and how these incidents should be processed. METHODS: The study involved an evaluation of clinical cases from our institution with a selective literature review and discussion of the medical device directive. RESULTS: The experience in our clinic showed that especially breakage of rasps in total hip and knee replacement surgery is associated with a major time extension of the operational procedure, a wider surgical access opening as well as complicated procedures to recover the fragments from the incident site. In individual cases a fenestration of the bone had to be conducted in order to collect the broken piece of the rasp. In one case a revision hip stem had to be used instead of the planned primary stem in order to bridge the fenestration site. CONCLUSION: Such consequences of instrument failure were considered to be a reportable incident. A thorough documentation as well as incident reporting to the manufacturer and the Federal authorities are required for a sufficient processing and risk assessment of the incident.