MAUDE Adverse Event Report: MAKO SURGICAL CORP. 3.0 RIO ROBOTIC ARM - MICS; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number 209999

Device Problems Application Program Problem: Parameter Calculation Error (1449); Incorrect, Inadequate or Imprecise Result or Readings (1535); Intermittent Communication Failure (4038)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/24/2020

Event Type  malfunction  

Manufacturer Narrative

As part of 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

Today at doctors hospital during our first of three total knee procedures, we had problems with registering the femur.After the first registration the overall accuracy number was 1.1, the points on the lateral portion of the femoral condyle were visibly proud even though the surgeon pressed down hard through cartilage and onto bone.We re-captured hip center, and the points went form 1.1 to 0.9, not improving much.We had him re capture all of the points, and slightly helped, but the error reading was still high, and the points still proud.After re doing, re-coaching and re-registering the femur a few more times, we were able to get it down to 0.6, but still the points were intermittently yellow on the lateral side.The surgeon has had this issue in the past, but never this high.He is demanding that we figure out what is happening since we have tried multiple solutions and ideas that we have received, but still has not solved the issue.We have verified that segmentation, landmarks, and proper registration technique is being followed, but still there is something that is throwing the femoral registration off that we need help identifying.Case type / application: tka.

Event Description

Today at doctors hospital during our first of three total knee procedures, we had problems with registering the femur.After the first registration the overall accuracy number was 1.1, the points on the lateral portion of the femoral condyle were visibly proud even though the surgeon pressed down hard through cartilage and onto bone.We recaptured hip center and the points went form 1.1 to 0.9, not improving much.We had him re capture all of the points and slightly helped but the error reading was still high and the points still proud.After re doing, re coaching and re registering the femur a few more times we were able to get it down to 0.6, but still the points were intermittently yellow on the lateral side.The surgeon has had this issue in the past but never this high.He is demanding that we figure out what is happening since we have tried multiple solutions and ideas that we have received but still has not solved the issue.We have verified that segmentation, landmarks, and proper registration technique is being followed but still there is something that is throwing the femoral registration off that we need help identifying.Case type / application: tka.

Manufacturer Narrative

Reported event.An event regarding registration fails involving a mako tka software was reported.The event was not confirmed.Method & results.-product evaluation and results: review of the log/session files has not been completed within 90days of the complaint being opened.The complaint will be closed with an associated risk assessment.Additional failures will be assessed once the log/session file review has been completed.-clinician review: no medical records were received for review with a clinical consultant.-product history review: a review of device history records shows that (b)(6) was inspected on 13 feb 2019 and the quality inspection procedures were completed with no reported discrepancies -complaint history review: a review of complaints in trackwise related to p/n 219999, robot number: (b)(6) shows 0 similar complaints for tka software - registration fails.Conclusions: the exact cause of the event could not be determined because insufficient information was made available for evaluation.Review of the log/session files has not been completed within 90days of the complaint being opened.A review of the case session/log data is needed to complete a full investigation for determining root cause.In addition to a review of the log/session, a field service engineer conducts scheduled maintenance on the robot to ensure the robot is system ready.Product surveillance will continue to monitor for trends.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.Device not returned.

• Brand Name: 3.0 RIO ROBOTIC ARM - MICS
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 10710359
• MDR Text Key: 212280146
• Report Number: 3005985723-2020-00316
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00848486030407
• UDI-Public: 00848486030407
• 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: 02/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 209999
• Device Catalogue Number: 209999
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/24/2020
• Initial Date FDA Received: 10/21/2020
• Supplement Dates Manufacturer Received: 01/20/2021
• Supplement Dates FDA Received: 02/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 68 YR