(b)(4).Date of event is unknown.Investigation results: the returned saw blade was noted to be broken right after the socket location.Visual analysis indicated the saw blade teeth were in good condition.There were no signs of wear and tear noted.The device was broken, with no additional indications of usage detectable.At the break point, a lateral load can be ascertained.A clear root cause is not identifiable.It is possible that this type of breakage would result following an impact or fall of the device while installed into the acculan 3ti machine.Hardness testing of the saw blade was performed and the device hardness was found to be within the allowable tolerance.Device history records were reviewed and found to be according to specification valid at the time of production.There have been no additional complaints reported for the lot number of the reported product.A material defect or manufacturing failure was not found.Corrective action is not required.
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