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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; STEREOTACTIC DEVICE, ROBOTICS
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MAKO SURGICAL CORP. 3.0 RIO® ROBOTIC ARM - MICS; STEREOTACTIC DEVICE, ROBOTICS Back to Search Results
Catalog Number 209999
Device Problems Fitting Problem (2183); Non Reproducible Results (4029)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/06/2018
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 case was planned for a size 3 femur and a size 2 tibia and the patient¿s bone was resected accordingly.When the surgeon went to trial the tibial baseplate he noticed that there were considerable gaps both lateral and medial and was not fitting both anterior and posterior, either.The pegs did not line up, as well.We went back to the implant planning page to confirm that the pre-planned size was a 2.Bone registration was done within recommended parameters.The surgeon then requested a size 3 baseplate trial to asses and found it to be a perfect fit per the resection that was made.The peg holes lined up and the only adjustment that had to be made was the normal posterior keel punch.The size 3 was trialed, confirmed and implanted into the patient.The surgeon liked the fit and feel of the size 3.Bottom line: the size 2 was selected and was resected but the size 2 trial did not fit.The size 3 fit and was implanted (no adjustments were ever made in the software to a size 3) pka-rom.
 
Event Description
The case was planned for a size 3 femur and a size 2 tibia and the patient¿s bone was resected accordingly.When the surgeon went to trial the tibial baseplate he noticed that there were considerable gaps both lateral and medial and was not fitting both anterior and posterior, either.The pegs did not line up, as well.We went back to the implant planning page to confirm that the pre-planned size was a 2.Bone registration was done within recommended parameters.The surgeon then requested a size 3 baseplate trial to asses and found it to be a perfect fit per the resection that was made.The peg holes lined up and the only adjustment that had to be made was the normal posterior keel punch.The size 3 was trialed, confirmed and implanted into the patient.The surgeon liked the fit and feel of the size 3.Bottom line: the size 2 was selected and was resected but the size 2 trial did not fit.The size 3 fit and was implanted (no adjustments were ever made in the software to a size 3)pka-rom.
 
Manufacturer Narrative
Reported event: an event regarding trial not fitting involving 3.0 rio robotic arm - mics, catalog: 209999 was reported.Method & results: device history review: a review of the dhr associated with rio 231 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 femoral trial not fitting.There were 5 other reported events (b)(4).Conclusion: product inspection could not be completed due to no logs or session files provided by mps after 3 communications.Device not returned.
 
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Brand Name
3.0 RIO® ROBOTIC ARM - MICS
Type of Device
STEREOTACTIC DEVICE, ROBOTICS
Manufacturer (Section D)
MAKO SURGICAL CORP.
2555 davie road
fort lauderdale FL 33317
MDR Report Key7848674
MDR Text Key119665810
Report Number3005985723-2018-00523
Device Sequence Number1
Product Code OLO
UDI-Device Identifier00848486030407
UDI-Public00848486030407
Combination Product (y/n)N
PMA/PMN Number
K170584
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 12/26/2018
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 Number209999
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 08/06/2018
Initial Date FDA Received09/05/2018
Supplement Dates Manufacturer Received12/11/2018
Supplement Dates FDA Received12/26/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
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