Model Number ROB00031 |
Device Problem
Naturally Worn (2988)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/09/2021 |
Event Type
malfunction
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Event Description
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It was reported that, during machine set up for a navio-assisted surgery, it was found that the navio bone pin 4.0mmx152mm (b)(4), the navio bone pin 4.0mm x 127mm (b)(4) and the navio handpiece thumberscrew (b)(4) had lost the threadings.No delays were reported.It is unknown how the procedure was completed.Patient outcome is unknown.
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Manufacturer Narrative
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The navio bone pin, part rob00031 used for treatment was not made available to the designated complaint unit for evaluation thus, a visual and functional evaluation could not be performed and a relationship between the reported event and the device could not be determined.While all products meet required manufacturing specifications prior to release a serial number or lot number is required to link the device to a dhr or nc investigation.A complaint history review for similar reported/confirmed complaints has identified prior events.Although the reported problem was not confirmed, a contributing factor may be natural wear and tear.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.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.
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Event Description
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It was reported that, during machine set up for a navio-assisted surgery, it was found that six (6) navio bone pins 4.0mmx152mm had lost the threadings.No delays were reported.It is unknown how the procedure was completed.Patient outcome is unknown.
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Manufacturer Narrative
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H3, h6: the six (6) navio bone pins, pn rob00031, lot # tu57762-02, intended for use in treatment, were returned for evaluation.A relationship between the reported event and the devices was established.The reported problem was visually confirmed.There is damage to the threads.The most likely cause of this event is product mishandling; external forces and/or pressure applied to the pin.Care and caution should be exercised during the surgical site setup, surgery and tear down to protect the device from an unforeseen force, such as falling onto a hard surface or damage.Refer to the navio surgical system user¿s manual for proper handling.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.A historical escalation event review was completed.A review of prior escalation actions found no actions applicable to the scope of this case.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.Internal complaint reference: (b)(4).
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Search Alerts/Recalls
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