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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 Use of Device Problem (1670); Insufficient Information (3190)
Patient Problems Bone Fracture(s) (1870); No Known Impact Or Consequence To Patient (2692)
Event Date 10/31/2017
Event Type  Injury  
Manufacturer Narrative
It was reported that the doctor decided to a stryker navigation system with the mako system after being advised against doing so. Utilizing the stryker navigation system with the mako robot is an off-label use. The difference in alignment noticed during surgery is therefore due to user error. The data at this time shows that the rio operated as expected. No system defect or malfunction is suspected.
 
Event Description
In the 2nd mako/strykernav case (10/31/2017), after making his cuts which were "acceptable" he manually completed the box cut for the ps femur. He impacted the trial and then noted that there was a fracture on the medial aspect of the femoral condyle. He then stated that "it didn't look like the box cut was big enough" and ordered an x-ray. He then opted to use a stryker ts fluted stem (12mm/100mm/ts) and a size 7 rt ts femur. He repaired the fracture with a screw and finished the knee procedure. There was a surgical delay of 15 minutes to repair the fracture.
 
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
In the 2nd mako/strykernav case (10/31/2017), after making his cuts which were "acceptable" he manually completed the box cut for the ps femur. He impacted the trial and then noted that there was a fracture on the medial aspect of the femoral condyle. He then stated that "it didn't look like the box cut was big enough" and ordered an x-ray. He then opted to use a stryker ts fluted stem (12mm/100mm/ts) and a size 7 rt ts femur. He repaired the fracture with a screw and finished the knee procedure. There was a surgical delay of 15 minutes to repair the fracture.
 
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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 Key7017442
MDR Text Key249799677
Report Number3005985723-2017-00538
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K170584
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 01/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/10/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number209999
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/21/2017
Was Device Evaluated by Manufacturer? No
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: 11/10/2017 Patient Sequence Number: 1
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