Model Number ROB00031 |
Device Problems
Defective Device (2588); Material Twisted/Bent (2981)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/14/2021 |
Event Type
malfunction
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Event Description
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It was reported that during set up for a navio assisted surgery, the navio bone pin 4.0mmx152mm were damaged.The procedure was completed, without delay, using the bone pins from the other set.Patient was not harmed as consequence of this problem.
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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, factors that may have contributed to the reported event may have been associated with natural wear and tear or damage.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 set up for a navio assisted surgery, the navio bone pin 4.0mmx152mm was bent.The procedure was completed, without delay, using the bone pins from the other set.Patient was not harmed as consequence of this problem.
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Search Alerts/Recalls
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