H6; the reported product involved with this event was returned for evaluation and the reported failure of drill bit breakage was confirmed.The drill bit was evaluated by product engineering who concluded that the heads of both the bits were not returned for analyses, meaning they could not be assessed for evidence that could indicate how the fracture occurred.The slight bends in both the bits, as well as the clean and homogeneous fracture surfaces, would suggest that an excessive bending force caused the fractures.It was also reported in this event that the drill bit was re-used.The instruction for use(ifu) for the handpiece for use with this drill bit contain the following caution under the warning section "excessive pressure can damage either the drill bit or driver." the ifu also contains the following warning; "¿ do not reuse, reprocess, or repackage asingle use device.".
|