Model Number ROB10013 |
Device Problem
Mechanics Altered (2984)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/03/2022 |
Event Type
malfunction
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Event Description
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It was reported that during a cori assisted tka surgery, the burr would spin but seemed to not extend out of the drill guard in exposure mode when it came down to the last 1 mm of bone (not take green off distal femur).No unintended additional bone cuts were performed.The procedure was completed, with a non-significant delay.In addition, the real intelligence robotic drill returned for evaluation and it was found that the exposure motor was loose.
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Manufacturer Narrative
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Internal complaint reference: case (b)(4).The real intelligence robotic drill, part number rob10013, serial number (b)(4) used in treatment was returned for evaluation.The software files were downloaded from the device and provided for investigation as well.Case id: (b)(4) was evaluated for the occurrence date of (b)(6) 2022.There were no auto or user-taken screenshots in the femur bone removal screen with the resulting green bone.Therefore, the reported complaint could not be confirmed.Visual and functional evaluations were done on the drill.There were no visual abnormalities, however, the drill failed multiple functional evaluations including the max homing torque and the homing range value of the robotic drill diagnostics kpc tests.The drill was also taken through the handpiece calibration verification stage of a case multiple times to see if the bur positioning would pass, where it failed three out of four times.It was suspected that the exposure motor had unthreaded, preventing full exposure of the bur.The screenshots and log file indicate the user had redefined the femur checkpoint after implant planning, just prior to cutting.Although the most likely cause is due to the loose exposure motor, the possibility of tracker movement as a contributing factor cannot be ruled out.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 and that the documented risk level is still adequate.A review of manufacturing records indicate the software 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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Manufacturer Narrative
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H3, h6: the real intelligence robotic drill, part number rob10013, serial number (b)(6) used in treatment was returned for evaluation.The software files were downloaded from the device and provided for investigation as well.Case id: (b)(4) was evaluated for the occurrence date of 3feb2022.There were no auto or user-taken screenshots in the femur bone removal screen with the resulting green bone to confirm the reported unremoved green bone from the distal femur.However, further investigation of the drill determined the loose exposure motor to be the likely cause of the bur¿s inability to remove the 1 mm of bone (green) because it could not fully extend past the drill guard, thus confirming the complaint.Visual and functional evaluations were done on the drill.There were no visual abnormalities, however, the drill failed multiple functional evaluations including the max homing torque and the homing range value of the robotic drill diagnostics kpc tests.The drill was also taken through the handpiece calibration verification stage of a case multiple times to see if the bur positioning would pass, where it failed three out of four times.It was suspected that the exposure motor had unthreaded, preventing full exposure of the bur.The screenshots and log file indicate the user had redefined the femur checkpoint after implant planning, just prior to cutting.Although the loose exposure motor was confirmed, the possibility of tracker movement as a contributing factor cannot be ruled out.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 and that the documented risk level is still adequate.A review of manufacturing records indicate the software 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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