The navio long attachment, pfsr110006, s/n (b)(6) intended for use in treatment was not returned for evaluation; thus a visual and functional evaluation could not be performed and a relationship between the reported event and the device could not be established.A review of manufacturing records indicate the device met all specifications upon release into distribution.A complaint history review for similar reported/confirmed complaints found similar events.Although the reported problem was not confirmed, a factor that may have contributed to the reported symptom may have been associated with disintegration of the internal bearings; causing an obstruction in the long attachment, leading to breakage during insertion or removal.A historical escalation event review was not completed.The product was not returned and no evidence was made available to link the complaint to an escalation event.The failure mode and associated risk have been anticipated within the risk file and the documented risk level is still adequate.Although no further containment or corrective action is recommended or required at this time, all complaints are monitored and trended through post market surveillance activities.If the product associated with this event is returned or provided at a future date, this evaluation will be reopened for investigation.
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