It was reported that during a navio tka procedure, when drilling the box, the surgeon hit the femoral bone pin.This damaged the bone pin (bent) making it unusable (it was no longer required either).It did not negatively affect the case (there were no delays and no injuries).No other complications were reported.
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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.A review of manufacturing and service records indicate the device met all specifications upon release into distribution.A complaint history review for similar reported/confirmed complaints has identified prior events.Although the reported problem was not confirmed, the most likely cause of this event is improper handling of the part.Based on the investigation, no further containment or corrective action is recommended or required at this time.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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