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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
Model Number 209999
Device Problem Output Problem (3005)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/04/2019
Event Type  malfunction  
Manufacturer Narrative
As part of the 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
On our second mako tka case of the day.The surgeon went to cut the distal femur, the saw check point was off.The mics got contaminated so have to put a new one on.Then we re-done rio registration.All check points passed we went to cut the lateral condyle which was fine and when he cut the medial side he noticed it cut 2 different planes.Checked it with a planor probe and it said 2mm deep.The surgeon wanted to make these a straight cut so proximalised the femur to cut he lateral the corresponding 2mm to make it a straight cut.Went back in all check points passed he noticed again the robot was cutting on 2 different planes.This time it was 5mm deep with the planor probe.At this point he lost his trust in the robot and had to revert to a manual case.He needed distal femur augments to correct this problem but unfortunately the nearest ones were 3 hours away.He waited with patient on the table for implants to arrive.Surgical delay: delay of 5 hours patient had and extended anaesthetic and high risk of infection.**update** the stryker field service engineer re-calibrated the robot and reported that the issue was due to a damaged base array.
 
Event Description
On our second mako tka case of the day.The surgeon went to cut the distal femur, the saw check point was off.The mics got contaminated so have to put a new one on.Then we re-done rio registration.All check points passed we went to cut the lateral condyle which was fine and when he cut the medial side he noticed it cut 2 different planes.Checked it with a plan or probe and it said 2mm deep.The surgeon wanted to make these a straight cut so proxiamlised the femur to cut he lateral the corresponding 2mm to make it a straight cut.Went back in all check points passed he noticed again the robot was cutting on 2 different planes.This time it was 5mm deep with the planor probe.At this point he lost his trust in the robot and had to revert to a manual case.He needed distal femur augments to correct this problem but unfortunately the nearest ones were 3 hours away.He waited with patient on the table for implants to arrive.Surgical delay: delay of 5 hours patient had and extended anaesthetic and high risk of infection.Update: the stryker field service engineer re-calibrated the robot and reported that the issue was due to a damaged base array.
 
Manufacturer Narrative
Reported event: mps reported robot off cutting to 5mm deep.The surgeon reverted to manual.Device evaluation and results: per (b)(4) - details of work performed to address/resolve the service order successfully looked over (b)(6) @ (b)(6) hospital, (b)(6).Carried out kinematic calibration on both left and right sides of robotic arm, checked all transmission cabling j1-j6 all with mako tolerances and specifications.Also carried out hass test to confirm normal functionality of the system.The system is ready for clinical use.Product history review: a review of device history records shows that on (b)(6) 2017 1 device was inspected and 1 device was placed on: qt 17-01-0030.A review of the data revealed that the non-conformances are not related to the failure alleged in this compliant.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 209999, serial number (b)(6) shows no additional complaints related to the failure in this investigation.Conclusions: system ready for clinical use.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.
 
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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 Key9191456
MDR Text Key175450610
Report Number3005985723-2019-00739
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 03/11/2020
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 Model Number209999
Device Catalogue Number209999
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 10/04/2019
Initial Date FDA Received10/15/2019
Supplement Dates Manufacturer Received02/13/2020
Supplement Dates FDA Received03/11/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Age69 YR
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