The product analysis was completed.One opened sample of part number 1884016hr, from lot number [no information] was received.The middle assembly tip had broken off at the spiral wrap which would have resulted in the reported event.The portion that became detached measured 0.46¿ long.The middle assembly would bind when turned by hand which is an indication internal damage or interference between assemblies.When viewed under magnification, there was deformation of the locking area that is consistent with excess pressure applied to the blade while in the handpiece.The middle tube spiral wrap outside diameter shall measure 0.1470¿ +0.0010¿ / -0.0000¿; the shrink tube shall have a nominal wall thickness of 0.0010¿ / +-0.0002¿ (some variability may occur after shrinking it on to the tube); the outer tube sheath inside diameter shall measure 0.160¿ / +-0.001¿.The outside diameter of the outer tube sheath reduced by as much as 0.012¿ in the radius / curve (0.184¿ to 0.172¿).Providing the wall thickness of the outer tube sheath had no significant change from the distal end to the radius / curve, by extrapolation - the range of clearance between assemblies, using the allowed tolerance, would be approximately 0.000¿ clearance to 0.003¿ interference fit.The clearance combined with the binding of the middle assemblies indicates insufficient clearance for proper function.It is possible the excess pressure resulted in deformation of the assemblies reducing the clearance; however, it is unlikely due to the strength of materials used in the outer tube sheath.The information more likely indicates the reduction of the diameter (flattening) occurred during the bending step in manufacturing.Due to the likely manufactured deformation of the components, it is likely that the user experience improper cutting / operation and in an attempt to resolve this, applied excess pressure.The device condition was out of specification as it relates to the complaint.If information is provided in the future, a supplemental report will be issued.
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