Model Number ROB10013 |
Device Problems
Break (1069); Noise, Audible (3273); Physical Resistance/Sticking (4012)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/07/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Internal complaint reference: (b)(4).The sample is under evaluation by manufacturing site.
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Event Description
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It was reported that, during set up for a cori assisted tka surgery, upon drill test, the real intelligence robotic drill would barely spin and sounded off.They tried to reset up twice, but still did not spin as it should.The procedure was finished with a smith and nephew back up device without delay.Since incident occurred before procedure, patient was not involved.Moreover, when the drill was disassembled during the investigation, it was noted that the drill motor shaft pin came out of the yolk.
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Manufacturer Narrative
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H3, h6: the real intelligence robotic drill, rob10013, (b)(6) intended for use in treatment was returned for evaluation.A relationship between the reported event and the device was established.The reported event was visually confirmed.The drill was disassembled and it was noted the drill motor shaft pin had come out of the yolk.Evidence of epoxy on the pin could not be determined.The pin detachment had caused damage in the motor housing producing metal shavings.A functional evaluation was performed.The reported problem was confirmed.An attempt at a kpc test was unsuccessful.The drill didn't rotate the bur.The drill was disassembled, removing the drill motor and replacing it with a known good drill motor.The drill was revaluated with the test motor and passed testing and reviewed a case successfully.The most likely cause of this event is deficiency of epoxy, stress and vibration in the drill motor slip shaft causing the pin, (component that allows the bur to rotated), to become detached.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.As a result of the risk assessment the documented risk file will undergo further investigation and possible adjustment by the site quality team.Although no further containment or corrective action is recommended or required at this time, all complaints are monitored through complaint investigation and post market surveillance activities.
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Search Alerts/Recalls
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