It was reported that when burring during a navio tka procedure, the handpiece connection error came up.They were prompted to re-home and the bur would not home.The anspach drill was stuck in the handpiece.They manipulated the anspach drill out, re-seated the bur and were able to move forward and continue the procedure with a delay of less than 30 minutes.No other complications were reported.
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The navio handpiece, part number pfsr110137, serial (b)(6) and intended to be used for treatment, was returned for evaluation.A relationship between the reported event and the device could not be established.The reported problem could not be visually confirmed.A functional evaluation was performed.The reported problem was not confirmed.The hp tests passed 3 times.No additional findings were observed that would induce the reported problem.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.No probable cause or contributing factors could be attributed to this complaint.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.
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