It was reported that during a navio ukr procedure, after implant planning when the surgeon wanted to burr the femur, the message handpiece exposure control motor failure appeared.They opened another navio set instrument to swap the handpiece to continue the procedure without issues.There was a delay of 10 minutes.After the surgery, both handpiece and anspach were tested and were fine.No other complications were reported.
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The navio handpiece p/n 110004, s/n (b)(6) used for treatment was returned for evaluation.Nothing was identified visually that contributed to the reported problem.A functional evaluation was performed.The reported problem was confirmed.The "could not communicate with handpiece error" appeared at the start of the handpiece test.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 is mishandling during shipping, storage, use or reuse of the device, wear and tear over time.The use of care and caution should be exercised during the surgical site setup and tear down to protect the drill and handpiece cable from sharp objects or from situations that pin the cable between two objects.Do not use excessive force on the drill and handpiece strain reliefs during the decontamination process to minimize separating the cable from the strain relief.Refer to the navio surgical system user's manual and the navio surgical system instrument kit cleaning and sterilization guide for proper handling.Based on the investigation, no further containment or corrective action is recommended or required at this time.
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