Manufacturing site evaluation: the blade is broken about 1/3 of the length from the distal end.The analysis of the fracture pattern illustrated a forced fracture due to overload.No pores, inclusions or foreign bodies could be found on the point of rupture.The edge is damaged, most likely caused by an overload situation, e.G.Too much pressure during cutting.Additionally, the damaged proximal end is also an indicator for an overload situation, e.G.Leverage during application.The device quality and manufacturing history records have been checked for all available lot numbers and found to be according to our specifications valid at the time of production.No similar incidents have been filed with products from this batch.Based on the information available as well as a result of our investigation the root cause of the failure is most probably related to an insufficient usage.The breakage of the blade was most likely caused by an overload situation, e.G.Leverage and/or too much pressure during cutting, e.G.Hard tissue or bone.A capa is not necessary.
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