It was reported that during set up for a navio assisted surgery, it was notices that navio bone pin 4.0mmx152mm (case-(b)(4)), navio bone pin 4.0mm x 127mm (case-(b)(4)) and navio handpiece thumberscrew (case-(b)(4)) had lost their threadings.It is unknown if there was a surgical delay and how the procedure was completed.
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The navio bone pin, part rob00031 used for treatment was not made available to the designated complaint unit 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 determined.While all products meet required manufacturing specifications prior to release a serial number or lot number is required to link the device to a dhr or nc investigation.A complaint history review for similar reported/confirmed complaints has identified prior events.Although the reported problem was not confirmed, a contributing factor may be natural wear and tear.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 at a future date, this evaluation will be reopened for investigation.
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