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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 03/05/2019
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
After making cuts, anterior-lateral gapping between implant and bone was identified.Case was finished with no patient harms auto arm accuracy test was done following case in which the robot successfully passed.I am requesting an investigation be completed for dr (b)(6) on why this situation could have occurred.Case type: tka.What is the estimated gap discrepancy pertaining to the anterior resection plane? as per the mps: 2mm gap discrepancy between planned vs outcome.No gaps in other resection planes.How was the 2mm anterior-lateral gapping between implant and bone measured, was a measurement device used? as per the mps: the gap was determined by the surgeon using a small white measuring tape, and the gap was consistent both med.And lat.
 
Event Description
After making cuts, anterior-lateral gapping between implant and bone was identified.Case was finished with no patient harms auto arm accuracy test was done following case in which the robot successfully passed.I am requesting an investigation be completed for dr (b)(6) on why this situation could have occurred.Case type: tka.What is the estimated gap discrepancy pertaining to the anterior resection plane? as per the mps: 2mm gap discrepancy between planned vs outcome.No gaps in other resection planes.How was the 2mm anterior-lateral gapping between implant and bone measured, was a measurement device used? as per the mps: the gap was determined by the surgeon using a small white measuring tape, and the gap was consistent both med.And lat.
 
Manufacturer Narrative
Reported event: an event regarding inaccurate resection during a total knee procedure involving 3.0 rio robotic arm - mics, catalog: 209999 was reported.Method & results: device history review: a review of the dhr associated with rio 704 found quality inspection procedures successfully passed.Complaint history: based on the device identification (pn 209999) the complaint databases were reviewed from 2011 to present for similar reported events regarding inaccurate resection during a tka procedure.There was one other reported event for the listed catalog number (pr 1537088, pr1419895, pr1427242, pr1440996, pr1407370, pr1419895, pr1427242, pr1433496, pr1443555, pr 1449671, pr1516994, pr1528344, pr 1549560, pr 1748126, pr 1765984, pr 1757777, pr 1748590, pr1910116, pr1910115, pr1973447, pr1999340, pr2007557, pr2027239 and pr1940380).Conclusion: an analysis of the warnings in the crisis log file, application workflow, implant plan, femur checkpoint values, femur registration values, rio registration and verification values, bone preparation checkpoint values, and cutting tool location was completed.No system defect or malfunction is suspected.
 
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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 Key8448735
MDR Text Key139736372
Report Number3005985723-2019-00258
Device Sequence Number1
Product Code OLO
UDI-Device Identifier00848486030407
UDI-Public00848486030407
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 06/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/25/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number209999
Was Device Available for Evaluation? No
Date Manufacturer Received05/30/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
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