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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAKO SURGICAL CORP. RIO SURGICAL ARM; STEREOTACTIC DEVICE, ROBOTICS

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MAKO SURGICAL CORP. RIO SURGICAL ARM; STEREOTACTIC DEVICE, ROBOTICS Back to Search Results
Catalog Number 203999
Device Problems Mechanical Problem (1384); Device Displays Incorrect Message (2591)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/14/2016
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
The surgeon was completing a total hip arthroplasty procedure using the robotic arm interactive orthopedic system (rio) when an encoder error occurred.The surgeon was able to finish the case manually.
 
Manufacturer Narrative
Reported event: the reported device was confirmed to be a j6 arm for hip with qd, p/n 207557, lot ro287.Device history review: review of the device history records indicates rob287, which includes the j6 segment, was manufactured and accepted into final stock on 06/23/2014.Device evaluation and results: according to gsp case (b)(4), the fse determined that the j6 encoder had delaminated from the hub.Complaint history review: a review of complaints related to the j6 arm shows 10 additional complaints since january 2015 related to the failure in this investigation.Conclusions: the failure was confirmed by the fse.Corrective action/preventive action: no action is required at this time as there is no indication to suggest a product non-conformity or unanticipated hazard.
 
Event Description
The surgeon was completing a total hip arthroplasty procedure using the robotic arm interactive orthopedic system (rio) when an encoder error occurred.The surgeon was able to finish the case manually.
 
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Brand Name
RIO SURGICAL ARM
Type of Device
STEREOTACTIC 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
michael mcavenia
2555 davie road
fort lauderdale, FL 33317
9546280700
MDR Report Key6185101
MDR Text Key62706623
Report Number3005985723-2016-00442
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K141989
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 01/31/2017
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 Catalogue Number203999
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 12/15/2016
Initial Date FDA Received12/19/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received01/31/2017
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 Sequence Number1
Patient Outcome(s) Hospitalization;
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