Catalog Number NPFS02000 |
Device Problems
Power Problem (3010); No Apparent Adverse Event (3189)
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Patient Problems
No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/02/2020 |
Event Type
Injury
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Event Description
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It was reported that, while burring the distal femur in a navio tka procedure, the anspach drill would not spin.They took apart the long attachment and bur to reassemble, but this did not work.They also unplugged the foot pedal and drill separately, but it did not work either.They also had to recalibrate, but the issue was not resolved.It looked like the handpiece was working, but the anspach drill just would not spin.The surgery was changed to manual procedure with a delay of fewer than 30 minutes.After the case, they tested the drill multiple times and it worked perfectly.There was no problem with either drill pedal or drill.No other complications were reported.
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Manufacturer Narrative
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The navio surgical system us, part number npfs02000, serial number sn (b)(6), used for treatment was not returned for evaluation.A relationship between the reported event and the device could not be established.Log files although submitted would have no information to add to the investigation.A complaint history review for similar reported/confirmed complaints has identified prior events.A review of manufacturing records indicate the device met all specifications upon release into distribution.Refer to the navio surgical system user¿s manual, section intraoperative workflow: patient and system setup, assembling the surgical drill for proper set up and handling.The failure mode and associated risk have been anticipated within the risk file.The risk level is still adequate.A historical review concluded that no prior escalation actions are applicable to the scope of the reported complaint.Although the reported problem was not confirmed through a visual or functional evaluation, factors contributing to the reported symptom may have been associated with a drill motor failure.Based on the investigation, the need for a corrective action is not recommended or required at this time.Should any additional information be received the complaint will be reopened.The failure mode will continue to be closely monitored through complaint investigation and trended through post market surveillance activities.
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Search Alerts/Recalls
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