Model Number ROB10016 |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/06/2021 |
Event Type
malfunction
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Event Description
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It was reported that, during a cori assisted ukr surgery, while removing bone on femur in exposure control they experience noise from bur rubbing against inside of real intelligence robotic drill guard before noticing the suction barb detaching from side of guard and breaking off (case-(b)(4)).They switch out the guard and experienced the same friction.They examined the bur to make sure it was clear of debris and replaced the guard a third time.Again they noticed the friction against the inside of guard (case-(b)(4)and case-(b)(4)).They decided to continue bone removal in speed control mode to finish the case, and made it without further issues.The barb broke off only from one of the three guards however all guards experienced the friction.The procedure was finished, without significant delay, using a smith and nephew back up device.The patient was not harmed beyond the reported problem.
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Manufacturer Narrative
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Internal complaint reference case-(b)(4).
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Event Description
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It was reported that, during a cori assisted ukr surgery, while removing bone on femur in exposure control they experience noise from bur rubbing against inside of real intelligence robotic drill guard before noticing the suction barb detaching from side of guard and breaking off.They switch out the guard and experienced the same friction.They examined the bur to make sure it was clear of debris and replaced the guard a third time.Again they noticed the friction against the inside of guard.They decided to continue bone removal in speed control mode to finish the case, and made it without further issues.The barb broke off only from one of the three guards however all guards experienced the friction.The procedure was finished, without significant delay, using a smith and nephew back up device.The patient was not harmed beyond the reported problem.
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Manufacturer Narrative
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H3, h6: the real intelligence robotic drill guard, part number: rob10016, lot: 1341425 used for treatment, was returned for evaluation.A relationship between the reported event and the device was established.The reported problem was visually confirmed.The barbed suction tube was completely detached.An outline consisting of weld material remains on the surface of the guard.There is no weld material remaining in the area just below the barb.A functional evaluation could not be performed due to the nature of the broken weld.A review of manufacturing records indicate the device met all specifications upon release into distribution.A complaint history review for similar reported/confirmed complaints found similar events.The most likely cause of the reported problem is an incomplete weld around the perimeter of the irrigation tube.As part of our continued process improvement a review of prior escalation actions has determined that this case and associated lot/serial number is related to a corrective/preventive action, nonetheless, no containment has been required.The real intelligence cori for knee arthroplasty user manual provides guidelines for recovering to a fully manual procedure in the "recovery procedure guidelines, appendix d".The failure mode and associated risk have been anticipated within the risk file and the documented risk level is still adequate.Per complaint details from the us, it was reported that during a cori assisted ukr surgery, while removing bone on femur in exposure control they experienced noise from bur rubbing against inside of real intelligence robotic drill guard before noticing the suction barb detaching from side of guard and breaking off.They replaced the guard two more times, again noticing the friction against the inside of guard.They decided to continue bone removal in speed control mode to finish the case, and made it without further issues.The barb broke off only from one of the three guards however all guards experienced the friction.The procedure was finished, without significant delay, using a smith + nephew back up device.The patient was not harmed beyond the reported problem.Further investigation into the reported failure and remediation is being conducted to determine if additional actions are required.The failure mode will continue to be closely monitored through complaint investigation and trended through post market surveillance activities.
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Manufacturer Narrative
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The manufacturer has identified that this event should be re-evaluated for mdr reporting.The detached component is of a size/shape that can be easily retrieved in its entirety and this malfunction has been resolved by using an available back-up device.Although this event may result in a short delay while the procedure is resumed and completed as intended, this malfunction has not caused or contributed, in the past, to a death or serious injury, nor has it been required a medical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.This malfunction is unlikely to cause any death or serious injury if it were to recur, either.Therefore, this event is considered non-reportable pursuant to 21 c.F.R.§803.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly, and a further report submitted outlining both the event details and our investigations performed.
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Search Alerts/Recalls
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