Product analysis found out that the reported event ¿broken and faulty out of the packet¿ insinuates that the device was defective before use in the package however the biological contaminants inside the device and outside indicate use.The middle assembly would index freely however the inner assembly with resistance which is typical of spiral wrap damage from excess speed or improper direction.The inner hub was 0.07¿ from its typical position in relation to the rotating hub which is consistent with a stretched spiral wrap.There was some wear to the cutting teeth however it is not likely a causal effect of the reported event.The blade loaded into a handpiece however due to the resistance of the inner assembly, and pressure from the stretched spiral wrap, it would not function.A review of the global complaint data showed no other similar complaints for this lot number.There was no evidence of improper manufacturing and therefore has been ruled out as a likely cause.The information most likely indicates irregular torsional loads from improper speed or direction resulted in the observed damage and lack of function.The labeled maximum recommended speed for this device is 3,000 rpm in oscillate mode / direction.The user¿s guide warns ¿powered blades should be operated in the oscillate mode only.Operating in the forward mode may cause damage to the blade.¿ if information is provided in the future, a supplemental report will be issued.
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