Model Number ROB10013 |
Device Problems
Unstable (1667); Calibration Problem (2890); Physical Resistance/Sticking (4012)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/18/2021 |
Event Type
Injury
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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 the calibration set up for a cori assisted surgery, the real intelligence robotic drill notified that it was almost time to service the drill but could still continue, however, when they hit continue, it would just quit out of case and not let them move forward.They went to admin screen to run a test on the handpiece and the bur would not even lock in to move through the test and the test kept failing.The ri robotic drill attachment was stuck on the real intelligence robotic drill after they tried calibrating.The procedure was completed, without delay, by changing in surgical technique.
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Manufacturer Narrative
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Results of investigation: the cori drill, p/n rob10013, (b)(6), intended for used in treatment was returned for evaluation.Nothing was identified visually that contributed to the reported problem.A functional evaluation was performed and the reported problem was confirmed.The drill was disassembled and the drill attachment was removed.It was found that the nut that rides the exposure motor lead screw was broken.This nut attaches to the carriage which allows it to move.The broken nut will not allow the carriage to travel to the position that allows the bur to be inserted, therefore confirming the complaint.Contributing factors for the broken lead screw nut could be general wear and tear or improper handling of the drill.Refer to the real intelligence cori for knee arthroplasty user manual ((b)(4)) for instructions on proper handling of the drill in disassembly and cleaning.The user manual also provides guidelines for recovering to a fully manual procedure in the "recovery procedure guidelines, appendix d".This situation is captured in the risk assessment released at the time of the complaint.The failure mode and associated risk have been anticipated within the risk file.As a result of the risk assessment the documented risk file requires further investigation and possible adjustment by the site quality team.A review of manufacturing records indicate the device met all specifications upon release into distribution.A complaint history review found similar reports.A review of prior escalation actions was performed and found no actions that are applicable to the scope of the reported complaint.This issue will be continuously monitored through complaint investigation and post market surveillance.Based on the investigation, no containment or corrective actions are recommended at this time.
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Search Alerts/Recalls
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