An event regarding an alleged malfunctioning of a securfit advanced broach handle was reported.The event was confirmed.Method & results: device evaluation and results: the device was returned in used condition.The device showed scratches, burrs and cuts throughout but was otherwise clean and in good condition.Examination of the returned device with material analysis engineer indicated that no mar is required.Fracture mode is consistent with a previous completed mar.It concluded that hook fractured due to an overload condition.Medical records received and evaluation: no medical records were received for review with a clinical consultant.Device history review: confirmed all devices accepted into finished goods conformed to specification.Complaint history review: there has been two other events for the lot referenced.Visual analysis showed that the device was returned in used condition.Examination of the returned device with material analysis engineer indicated that the fracture mode is consistent with previous completed mar.Therefore, it is concluded that the alleged malfunctioning of the device was the result of a fracture due to overload conditions.No further investigation for this event is possible at this time.If additional information becomes available, this investigation will be reopened.
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