Model Number ROB10013 |
Device Problems
Intermittent Continuity (1121); Overheating of Device (1437); Connection Problem (2900); Physical Resistance/Sticking (4012)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/04/2022 |
Event Type
malfunction
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Event Description
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It was reported that, during a cori assisted tka surgery, the real intelligence robotic drill stopped working, the bur was not properly inserted.They swapped to a new real intelligence robotic drill and when the surgeon went to bur, the drill itself felt very hot instantly.The surgeon said it was not the guard part, but the entire drill itself.It is unknown how the procedure was completed.A significant delay was reported and the patient outcome is unknown.After the case, they were unable to get the ri robotic drill attachment and the real intelligence robotic drill tracker from both drills.
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Manufacturer Narrative
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Internal complaint reference: (b)(4).
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Event Description
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It was reported that, during a cori assisted tka surgery, the real intelligence robotic drill stopped working, the bur was not properly inserted.They swapped to a new real intelligence robotic drill and when the surgeon went to bur, the drill itself felt very hot instantly.The surgeon said it was not the guard part, but the entire drill itself.The procedure was completed with the second drill with a significant delay.The patient was not harmed.After the case, they were unable to get the ri robotic drill attachment and the real intelligence robotic drill tracker from both drills.
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Manufacturer Narrative
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H3, h6: the real intelligence robotic drill, rob10013, sn000229, used for treatment was returned for evaluation.A relationship between the reported event and the device was established.Nothing was identified visually that contributed to the reported problem.A functional evaluation was performed.The reported problem was confirmed.(connection problem) a kpc test was attempted but was unsuccessful.A critical error displayed during the kpc testing.A case was attempted as well, and the system showed a timeout error followed by a drill flicker icon at the connection screen.The exposure motor was removed and retained for further analysis.Drill performed as intended after exposure motor swap.The most likely cause of this event is an electrical communication failure of the drill exposure motor encoder.(physical resistance/sticking) following removal of the drill attachment, the retaining nut was out of torque specification, causing to become stuck in the drill.Another drill attachment was assembled and disassembled with no issues.The most likely cause of this event is the drill attachment retaining nut was out of torque specification.(overheating of device) during the drill attachment and bur load process the exposure motor is intentionally extended for 60 seconds (for both bur and drill attachment) which causes it to warm up.Although this event was not confirmed, a factor that may have contributed to the reported symptom may have been related to the user extending the insertion period to the full 120 seconds which would have allowed the drill to warm up for 120 seconds.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.The review determined that prior escalation actions are applicable to the scope of this complaint and further investigation into the reported failure is being conducted to determine if additional escalation actions are required.The failure mode and associated risk have been anticipated within the risk file and the documented risk level is still adequate.The failure mode will continue to be closely monitored through complaint investigation and trended through post market surveillance activities.
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Search Alerts/Recalls
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