MAUDE Adverse Event Report: MAKO SURGICAL CORP. 3.0 RIO ROBOTIC ARM - MICS; STEREOTAXIC DEVICE, ROBOTICS

Catalog Number 209999

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Inadequacy of Device Shape and/or Size (1583); Insufficient Information (3190)

Patient Problems Injury (2348); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/16/2020

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

As reported: "as i recall, we started the case as the scrub tech was putting the leg holder on the bed she tightened it but it wasn't tight enough and it fell on the floor.We exchanged that leg holder for a competitor boot and re-prepped and re-draped the patient.We trialed and the doctor told me multiple times that it was loose in extension which was what was explained to him on the graph prior to bone prep.He said that the graph would not have made him so loose.I told him if he was concerned that we did not burr to plan we could check our checkpoints to ensure that our arrays and the cutter did not move.He the put his probe in the femoral checkpoint with one hand then went to ensure the array was tight with the other.The array could have been tighter and with some force he was able to move it after jiggling it around a bit but during the case i didn't see from its original location.Surgeon: during trialing the patient was loose in flexion with a 10mm poly.I built up a cement mantle to place the femur on.Post-op rom 5-80 degrees at present.Entirely due to component position.This patient will need a manipulation.Update: as per response, patient will have manipulation under anesthesia.

Event Description

As reported: "as i recall, we started the case as the scrub tech was putting the leg holder on the bed she tightened it but it wasn't tight enough and it fell on the floor.We exchanged that leg holder for a competitor boot and re-prepped and re-draped the patient.We trialed and the doctor told me multiple times that it was loose in extension which was what was explained to him on the graph prior to bone prep.He said that the graph would not have made him so loose.I told him if he was concerned that we did not burr to plan we could check our checkpoints to ensure that our arrays and the cutter did not move.He the put his probe in the femoral checkpoint with one hand then went to ensure the array was tight with the other.The array could have been tighter and with some force he was able to move it after jiggling it around a bit but during the case i didn't see from its original location.Surgeon: during trialing the patient was loose in flexion with a 10mm poly.I built up a cement mantle to place the femur on.Post-op rom 5-80 degrees at present.Entirely due to component position.This patient will need a manipulation.Update: as per response, patient will have manipulation under anesthesia.

Manufacturer Narrative

Reported event: it was reported, "as i recall, the case started dr.And i went over the case and he made adjustments to the plan according to what he wanted.We started the case as the scrub tech was putting the leg holder on the bed she tightened it but it wasn't tight enough and it fell on the floor.We exchanged that leg holder for a competitor boot and re-prepped and re-draped the patient.Dr.Had the leg in extension and i mentioned that the leg should be at 90 degrees to prevent the quad from tearing he responded with i have always put the pins in this way and continued.He proceeded to put the pins in and put the arrays on being reminded and watched to tighten them.He then made his incision.Upon adjusting flexion for bone registration a lap was in the way on the competitor boot he went to move it and poked a hole in the drape with the blue probe contaminating it.He then tossed it on the mayo stand further contaminating the instruments on the mayo stand.He breaks scrub and leaves the room for about 15 minutes.I then leave to grab new instruments to replace the contaminated ones.After everything is set back up he comes back in and gowns back up and we proceed.Bone registration was good and accuracy was under.5 with a good spread and on all three planes of the bone and we were able to further verify the blue spheres.We continue to joint balancing and the implant planning he made his desired adjustments to the implant and agreed to the plan after having the graph and values explained to him.I made him aware multiple times that he would be loose in extension with the shown values.He said "i'm ok with that".We checked our tracking, mapped our cartilage and checked our acl on our tibia.We checked the graph again before going into bone prep to ensure that it was as desired before moving into bone prep.He still agreed, i moved the robot in and he registered the robot intra-op.Check points passed, we proceeded to ct view and ensured the burr was on bone and then burred.All checks (checkpoint, ct view burr to bone, and cutter check all passed every time they were checked).After all cuts were completed i moved the robot out and he cleaned up the bone and prepped it to be able to trial.We trialed and he told me multiple times that it was loose in extension which was what was explained to him on the graph prior to bone prep.He said that the graph would not have made him so loose.I told him if he was concerned that we did not burr to plan we could check our checkpoints to ensure that our arrays and the cutter did not move.He then put his probe in the femoral checkpoint with one hand then went to ensure the array was tight with the other.The array could have been tighter and with some force he was able to move it after jiggling it around a bit but during the case i didn't see from its original location.Surgeon: during trialing the patient was loose in flexion with a 10mm poly.I built up a cement mantle to place the femur on.Post-op rom 5-80 degrees at present.Entirely due to component position.This patient will need a manipulation." update: as per response, patient will have manipulation under anesthesia.¿ method & results: product evaluation and results: a review of this case shows that there were no issues with the mako robotic system based on the data provided in the logs.All accuracy numbers for bone and rio registration were in the acceptable range.There did not appear to be any events that would suggest accuracy in the system would be loss such as unwanted errors or velocity traps.Because kinematic showed that with the planned implant placement there would be joint looseness in extension its expected that the final implantation was loose.The data for this case suggest the mako robotic system behaved as expected.Product history review: a review of device history records shows that rob238 was inspected on 26 february 2013 and the quality inspection procedures were completed with no reported discrepancies.Complaint history review: a search of the complaint database under device identification pn 209999, rob238 reports no similar complaints for pka software - incorrect selection conclusions: the failure was reviewed through return of the provided log/session files.All quality metrics were found to be within range.Bone and rio registration was acceptable.Kinematic showed that with the planned implant placement there would be joint looseness in extension then its expected that the final implantation was loose.It is noted that the mps informed the surgeon of this before bone preparation.The data for this case suggest the mako robotic system behaved as expected.No additional investigation or specific actions are required at this time.If additional information is received, then the complaint will be reopened.System is ready for use.

• Brand Name: 3.0 RIO ROBOTIC ARM - MICS
• Type of Device: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 9837669
• MDR Text Key: 183772408
• Report Number: 3005985723-2020-00161
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 12/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 209999
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention