Device evaluated by mfr:the shaft of the returned device was visually and microscopically inspected for damage.The device showed a separation located 3cm from the tip.The total wire (185cm) was returned and accounted for.Functionality of the device could not be confirmed due to the damage of the device.The coefficient was confirmed to be programmed per specification.The device showed kinks and bends throughout the wire length.A scanning electron microscopy examination was performed which identified distal end failure, post failure damage, striations, and dimpling at the center support.The proximal end identified post failure damage, striations, and a raised center line.This type of damage may have been caused by reverse bending fatigue with possible ductile overload which is indicative of failures in the slotted tube region.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The complaint of device separation was confirmed.
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