Manufacturing site evaluation: the complained devices are available in a decontaminated condition for investigation.Tibia cutting guide has a metal burr on the side.According to the available information, there were no negative consequences for patient.Investigation: sharp-edged burrs at the outer ends of the cutting slot.The components were examined visually and microscopically with the digital microscope vhx-5000 keyence eq.-nr.2000024840 and the digital-camera "panasonic dmc tz8".The complained devices were sent to the responsible manufacturing department for investigation: "on the production side no failure could be found." batch history review: the device quality and manufacturing history records have been checked for the available lot numbers and found to be according to our specification valid at the time of production.Conclusion and root cause: based on the information available as well as a result of our investigation the root cause of the failure is most probably usage related.Rationale: there are no hints for a material problem.According to the quality standard and dhr files a material defect and production error was not found.According to the manufacturing process and specified targets it can be excluded that the device has left aag with such sharp-edged burrs at the outer ends of the cutting slot.Most probably the device was not used as intended.
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