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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 Device Displays Incorrect Message (2591); Connection Problem (2900)
Patient Problems Discomfort (2330); No Known Impact Or Consequence To Patient (2692)
Event Date 03/13/2017
Event Type  Injury  
Manufacturer Narrative
Reported event: the returned device was confirmed to be a 3. 0 rio® robotic arm - mics, catalog # 209999, serial# (b)(4) that had connection errors. Device history review: a review of the device history records show that 209999, serial# (b)(4) was built and passed all qips as evidenced by the quality review and signature which was completed on janaury 6, 2017. Device evaluation and results: from the information provided the 502 error which is a communication error was not able to be detected, however, a subsequent connection error was observed in the system report. From the attached emails the failure was narrowed down to an ethernet cat5 to fiber converter, catalog# 200933. The items was replaced and the system returned to full function. As a result of a similar incident the system was returned to stryker and per gsp case# 149190 the connection errors were confirmed. The cpci was replaced and subsequent testing declared the system ready for clinical use. Complaint history review: a review of complaints in trackwise related to p/n 209999, serial number (b)(4) and p/n 200933 ethernet cat5 to fiber converter shows three additional complaints related to the failure in this investigation. The complaints are pr# 1488459, 1515423, 1515424. Conclusions: the failure mode of a. 0 rio® robotic arm - mics with connection errors was confirmed. The issue occurred during a case and resulted in its cancellation. The failure was narrowed down to a faulty cat5 to ethernet converter which was replaced during the service visit. Corrective action/preventive action: no further action is required.
 
Event Description
The surgeon was completing a partial knee arthroplasty procedure using the robotic arm interactive orthopedic system. The mako system encountered an error 502 during a procedure. Trouble shooting was carried out and engineering contacted for support during the procedure. The error was not able to be resolved therefore the case was aborted. The patient had an incision made and bone pins placed in the tibia and femur. Osteophytes were also removed. The patient's wounds were closed without beginning to burr bone. The procedure was not completed and will be rescheduled for a later date.
 
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
The surgeon was completing a partial knee arthroplasty procedure using the robotic arm interactive orthopedic system. The mako system encountered an error 502 during a procedure. Trouble shooting was carried out and engineering contacted for support during the procedure. The error was not able to be resolved therefore the case was aborted. The patient had an incision made and bone pins placed in the tibia and femur. Osteophytes were also removed. The patient's wounds were closed without beginning to burr bone. The procedure was not completed and will be rescheduled for a later date.
 
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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
liza gordillo
2555 davie road
fort lauderdale, FL 33317
9546280700
MDR Report Key6411449
MDR Text Key199986669
Report Number3005985723-2017-00125
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeAU
PMA/PMN Number
K112507
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 07/24/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/16/2017
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 Received07/24/2017
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: 03/16/2017 Patient Sequence Number: 1
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