One single 72201518 disposable 2.9mm mini magnetic abrader blade used in treatment, was not returned for evaluation.This product is sold as a box of six.This product is not intended to be sold individually.Due to product unavailability, the complaint nor relationship to event could be confirmed.Conclusions, were limited without physical product.If information becomes available the complaint may be revisited.This is a small scale blade for lighter applications.Skiving is a symptom of excessive side loading and can create shedding.Per instructions for use: ¿excessive ¿side-loading¿ on the blade during use does not improve cutting performance, and in extreme cases may result in wear and degradation of the inner blade.Do not allow the rotating portion of any blade or burr to touch any metallic object such as a cannula or arthroscope.Damage to both instruments is likely.Damage to the blade can range from a slight distortion or dulling of the blade edge to actual fracture of the tip in vivo.If such contact does occur, inspect the tip.If there are cracks, fractures or dulling, or if there is any other reason to suspect a blade is damaged, replace it immediately.¿ influences unrelated to manufacture that could compromise product performance or integrity include:
1) blade hand piece not properly loaded (and locked) for specific mdu base choice.2) incompatible force or torque or leverage applied.3) change of approach during use.4) engaging the device without suction or insufficient irrigation.5) seizing of blades due to poor bio matter excision.Complaint history review indicated no similar allegations for the lot number reported but the two opened for this case.Batch review did not indicate a condition, product or procedure failure that supported the allegation.Instructions for use contains recommendations and precautionary statements for proper use of product.Risk management files contain the reported failure.No root cause related to the manufacture of the device was confirmed.Product met specifications upon release to distribution.
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