It was reported that two new blades broke as soon as drill cut was started.In this case, it would have been possible for a piece of the blade to have ended up inside the patient.Fortunately, this did not happen when the blade was outside the patient when the piece came off.
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In the case of the claimed article (b)(4) with the lot sn01 it was found during inspection that the inner blade jaw part is broken off.On the inside of the outer shaft a discoloration is visible, most likely caused by thermal damage.It is concluded that cooling was probably neglected here, which led to heat development and as a result the fracture occurred at the distal end.In the instructions for use of the article it is stated that insufficient irrigation and suction may lead to damage to the product, that irrigation and suction must be monitored and controlled throughout the entire procedure and to check the product for any blocked channels or damage.It is furthermore stated to check the product for functionality, damage and changes to the surface and to not overload the product with mechanical stress.Based on the damages found on the article, it is assumed that this is a case of non-compliance with the ifu/processing instructions.The event is filed under internal karl storz complaint id: (b)(4).
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