The affected product was discarded by the clinic and not available for further investigation.It was manufactured in the year 2011.The manufacture date could not be narrowed down any further.This means it was in use for more than 8 years when it failed.We have asked for photos of the damage, but these could not be provided.No pre-damage was recognized prior to use by the user.Without being able to investigate the product, we cannot determine for sure the root cause for the damage.The following root causes might have contributed to the damage.Overload: in the instructions for use, it is stated that the maximum permissible tensile load of the product is 700 newton (n).Maybe the product was loaded with more then the stated maximum permissible tension load which might have contributed to the incident.Material fatigue due to wearing and unsuitable reprocessing: the product was in use for more than 8 years.It cannot be excluded that material fatigue occurred due to the long period of use and frequent cleaning and disinfection.Possibly the material was additionally damaged due to mistakes during cleaning and disinfection.Such mistakes might be e.G.: residues of detergent or disinfectant left on the product, product not wiped dry after cleaning or disinfection or the use of unsuitable cleaning agents and disinfectants.The clinic told that the affected patient is fine and could leave the clinic.The fracture healed.Getinge-maquet gmbh provides product failure investigation, analysis and resolution for the device described in this report.H3 other text : device not returned.
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