Please see below response sent to the customer."reading through the complaint report, when the surgeon made the incision, it was noticed that the tip of the blade was missing.After 30 minutes, the tip of the blade was found in the knee.With this carbon sterile sm10 blade breaking during surgery, we must report this to the relevant competent authorities as it falls into the category of an adverse incident.Thank you for returning the broken blade in question for us to investigate, firstly we had to process it through our irradiation facility to ensure it was safe to handle.We then checked the heat treatment hardness on our calibrated hardness testing machine where we achieved a reading of 837hv proving that the blade had been manufactured to our in-house tolerance and the surgical blade standard bs 2982.With the use of the above lot number, we have been able to check our in-process records and we have been unsuccessful in identifying any problems that could be connected to this broken blade.Checking back through our history, we can also inform you that we have received no further customer complaints of this nature of which we produced and sold 569,400 carbon sterile sm10 blades.Considering the results from the heat treatment hardness test indicating that the blade had been manufactured to the surgical blade standard bs 2982, the only explanation we can offer is that you informed us that the tip of the blade was found in the knee, if there was any twisting or excessive lateral pressure in or around the knee, this could have caused the blade to break.Once again thank you for returning the broken blade in question for us to investigate and if we can be of any further assistance, please do not hesitate to contact us".
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