The completed product analysis confirmed that one opened sample of part number 1884080em from lot number 0215334243 and was manufactured april 25, 2018; there was a residue consistent with biological contaminants on the device.The reported failure was that the tip of the blade broke off , and visually, the distal tip had broken off the inner cutter, resulting in the reported event.The portion that became detached measured approximately 0.25¿ in length, where the break occurred at the first proximal tooth valley.The outer assembly was deformed in such a way that indicates the inner blade teeth impacted the outer teeth at the 4th proximal valley while moving in a clockwise direction.There was excess wear on the shaft 0.625¿ from the distal face of the inner hub, which can occur with excess pressure being applied to the blade during use; however, it is more likely the wear is a symptom of the breakage.There was no evidence of concentricity issues or bending in the outer tube, and uneven wear at the cutting tip may indicate an interference fit between the inner and outer assemblies at the tip.The customer complaint was confirmed, and there was an out of specification condition identified as it relates to the complaint.If information is provided in the future, a supplemental report will be issued.
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