Model Number PFSR110137 |
Device Problem
Mechanics Altered (2984)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/07/2021 |
Event Type
malfunction
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Event Description
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It was reported that, when they started burring the femur in a navio-assisted surgery, they got an error that displayed "handpiece pfs motor failure message" while using the navio handpiece.A back up handpiece was used, but the same error was displayed.So, they quit the case, re-entered it and proceed without any issues.The procedure was completed without significant delay (3 minutes), and patient was not harmed.
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Manufacturer Narrative
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H3, h6: the navio handpiece, pfsr110137, sn (b)(6), used for treatment was returned for evaluation.A relationship between the reported event and the device could not be established.Nothing was identified visually that contributed to the reported problem.A functional evaluation was performed.The reported problem was not confirmed.The handpiece completed the admin screen self test without any errors.A mock case was completed and no errors presented.Although the reported problem was not confirmed through a visual or functional evaluation, a factor that may have contributed to the reported symptom may have been associated with an siu firmware bug that would have corrected itself following the next system reboot.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 found similar events.A historical escalation event review was completed.A review of prior escalation actions found no actions applicable to the scope of the reported complaint.The failure mode and associated risk have been anticipated within the risk file and the documented risk level is still adequate.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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Search Alerts/Recalls
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