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U.S. Department of Health and Human Services

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

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MAKO SURGICAL CORP. 3.0 RIO® ROBOTIC ARM - MICS STEREOTAXIC DEVICE, ROBOTICS Back to Search Results
Catalog Number 209999
Device Problems Computer Software Problem (1112); Output Problem (3005)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/12/2019
Event Type  malfunction  
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
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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Brand Name3.0 RIO® ROBOTIC ARM - MICS
Type of DeviceSTEREOTAXIC DEVICE, ROBOTICS
Manufacturer (Section D)
MAKO SURGICAL CORP.
2555 davie road
fort lauderdale FL 33317
Manufacturer (Section G)
MAKO SURGICAL CORP.
2555 davie road
fort lauderdale FL 33317
Manufacturer Contact
bethany hinson
2555 davie road
fort lauderdale, FL 33317
9546280700
MDR Report Key8391885
MDR Text Key138141083
Report Number3005985723-2019-00203
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/06/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/05/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number209999
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/25/2019
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 03/05/2019 Patient Sequence Number: 1
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