An event regarding an alleged fracture involving a trident driver shaft was reported.The event was confirmed.Method & results: -device evaluation and results: device was returned in used condition and was broken into two pieces.The flexible shaft had separated near the point of juncture with the drive fitting.At the point of separation, individual flexible shaft cables were twisted and frayed.Examination of the returned device with material analysis engineer indicated fracture consistent with overload.-medical records received and evaluation: no medical records were received for review with a clinical consultant.-device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies.-complaint history review: there has been no other event for the lot referenced.Conclusions: the reported event was confirmed.The flexible shaft had separated near the point of juncture with the drive fitting.At the point of separation, individual flexible shaft cables were twisted and frayed.Further examination of the returned device with material analysis engineer indicated fracture consistent with overload.No further investigation is required at this time.If the devices and/or additional information are received, this investigation will be reopened and re-evaluated.
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