Catalog Number PFSR101209 |
Device Problem
Interrogation Problem (4017)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/05/2020 |
Event Type
malfunction
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Event Description
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It was reported that, during femur cut stage of a navio tka procedure, it was found that the error activated on the anspach drill console.The anspach drill was reconnected and the assembly rechecked (long attachment, burr drill and handpiece) was correct, but the error persisted.No cuts could be done by this drill.They swapped for the drill for its backup to continue with a delay of fewer than 30 minutes.After the surgery, the anspach drill was checked in the admin mode and, as soon as the drill was connected to the console, the error was activated.The drill was confirmed faulty.No other complications were reported.
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Manufacturer Narrative
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H3, h6: the navio drill, part number: 101209, s/n: (b)(6), used in treatment, was not returned 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.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.Although the reported problem was not confirmed, a factor that may have contributed to the reported symptoms may have been an electronic component failure.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 or provided at a future date, this evaluation will be reopened for investigation.
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Manufacturer Narrative
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H3, h6: the anspach emax 2 plus hand piece - rohs, part number pfsr101209, serial (b)(6) and used for treatment, was returned for evaluation.A relationship between the reported event and the device was established.The reported problem could not be visually confirmed.A functional evaluation was performed.The reported problem was confirmed.A performance verification was followed.The customer handpiece was connected to the navio console and an "e6" error was outputted.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 probable cause of the reported problem is electrical failure within drill cable.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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