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Catalog Number 209999 |
Device Problems
Computer Software Problem (1112); Output Problem (3005)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 02/12/2019 |
Event Type
malfunction
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Manufacturer Narrative
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As part of the normal complaint follow-up, an evaluation of the event has been initiated by mako surgical.A supplemental report will be submitted when additional information becomes available.
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Event Description
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Case type: tka.Surgical delay: 30 minutes.Was the patient under anesthesia during the surgical delay? yes/no.As per the mps: the patient was under for the delay.The delay was used to perform other sequences of the procedure that did not require the use of the robot.What is the estimated discrepancy for flexion, varus, etc that was mentioned in the complaint? as per the mps: i wasn¿t able to document the numbers, but to the best of my memory it was a 14 degree varus deformity with a 20 degree flexion contracture.During a tka case, all registration and fine registration were completed without issue.Upon balancing, the numbers shown on the screen (flexion, varus, etc) did not match what was seen clinically.The numbers were extreme and were presumed to be incorrect.Upon noticing this, the mps asked the surgeon to take the leg through the range of motion and decided to confirm all previous steps, including resection points, landmarks, segmentation and patient information.The ct landmarks page displayed the magenta line completely offset for both the tibia and the femur (the magenta line was no longer aligned to the cortical bone).This is a known software bug within the planning laptop so the mps proceeded to leave the page and come back which corrected the error, on the ct landmarks page, but upon going back to the balancing page, the numbers remained incorrect.The mps returned to the ct landmarks page again and the magenta line was offset again.This process was repeated with a software reset and a robotic system reset, both of which temporarily fixed the segmentation until the balancing page which then displayed the same error when returning to the ct landmarks page.The case was converted to a manual case after running through all possible troubleshooting sequences and consulting the mako sos hotline.Provide more detail: the issue was noticed by the mps.There were no warnings, alarms or hard stops that prevented the progress of the case.The severity of this issue is very high as there was no systematic 'software stop' that prevented the following steps in the case.Although it is unknown what the outcome could have been, the mps and surgeon did not believe that the corrections and cuts made by those corrections would have been accurate.
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Event Description
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Case type: tka.Surgical delay: 30 minutes.Was the patient under anesthesia during the surgical delay? yes/no.As per the mps: the patient was under for the delay.The delay was used to perform other sequences of the procedure that did not require the use of the robot.What is the estimated discrepancy for flexion, varus, etc that was mentioned in the complaint? as per the mps: i wasn¿t able to document the numbers, but to the best of my memory it was a 14degree varus deformity with a 20degree flexion contracture.During a tka case, all registration and fine registration were completed without issue.Upon balancing, the numbers shown on the screen (flexion, varus, etc) did not match what was seen clinically.The numbers were extreme and were presumed to be incorrect.Upon noticing this, the mps asked the surgeon to take the leg through the range of motion and decided to confirm all previous steps, including resection points, landmarks, segmentation and patient information.The ct landmarks page displayed the magenta line completely offset for both the tibia and the femur (the magenta line was no longer aligned to the cortical bone).This is a known software bug within the planning laptop so the mps proceeded to leave the page and come back which corrected the error, on the ct landmarks page, but upon going back to the balancing page, the numbers remained incorrect.The mps returned to the ct landmarks page again and the magenta line was offset again.This process was repeated with a software reset and a robotic system reset, both of which temporarily fixed the segmentation until the balancing page which then displayed the same error when returning to the ct landmarks page.The case was converted to a manual case after running through all possible troubleshooting sequences and consulting the mako sos hotline.Provide more detail: the issue was noticed by the mps.There were no warnings, alarms or hard stops that prevented the progress of the case.The severity of this issue is very high as there was no systematic 'software stop' that prevented the following steps in the case.Although it is unknown what the outcome could have been, the mps and surgeon did not believe that the corrections and cuts made by those corrections would have been accurate.Case type: tka.Surgical delay: 30 minutes.
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Manufacturer Narrative
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Reported event: an event regarding a visual shift in ct landmarks during a total knee procedure involving 3.0 rio robotic arm - mics, catalog: 209999 was reported.The 3d bone model/ct landmarks being off bone when user enters ct landmarks page right from ligament balancing page is a known issue which does not pose any harm to patient safety.Per nc (b)(4), it was found that the ct landmarks remain unchanged.
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Search Alerts/Recalls
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