It was reported that, after a cori tka, they noticed that the white part (scraper at the end of the attachment, inside) was separated from the robotic drill attachment.Since the incident occurred after the procedure, there was no patient involvement.No other complications were reported.
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H3, h6: the cori drill attachment p/n rob10015 (b)(6), intended for use in treatment was returned.The reported problem was confirmed.The wiper is separated from the drill attachment.No epoxy is visible around the crown for adhesion.Although the reported problem was visually confirmed a functional evaluation was performed.A drill test was run and the passed.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.The most likely cause of this event was lack of epoxy applied during manufacturing.Based on the investigation, no further containment or corrective action is recommended or required at this time.
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