MAUDE Adverse Event Report: MAKO SURGICAL CORP. 3.0 RIO® ROBOTIC ARM - MICS; STEREOTAXIC DEVICE, ROBOTICS

Catalog Number 209999

Device Problems Device Operates Differently Than Expected (2913); Insufficient Information (3190)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/30/2017

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

On thursday, (b)(6) 2017, i was attempting to do rio setup for right tka with surgical tech but continuously got error ¿burr mismatch¿.There was also a message on the screen to release the trigger on the handpiece, however the trigger on the mics was not being pressed.Reset arm software, reset cutter, and did soft reboot but still got the same error.Swapped out the mics handpiece and the same thing happened, ¿burr mismatch error¿.Went to mics status check and got error ¿reference to non-existent field ¿failuremsg¿.¿ did hard shut down and the surgeon re-homed the robot.Went into rio setup and still got the error.Shut down the robot completely again, rehomed the robot, and we were able to successfully complete rio setup and rio registration and the case was completed successfully.Surgical delay of less than 30 minutes.Files uploaded in the complaints folder 11.30.2017 (b)(6) tka.

Manufacturer Narrative

"reported event: while attempting to do rio setup for right tka with surgical tech but continuously got error ¿burr mismatch¿.Device evaluation and results: reset arm software, reset cutter, and did soft reboot but still got the same error.Swapped out the mics handpiece and the same thing happened, ¿burr mismatch error¿.Went to mics status check and got error ¿reference to non-existenet field ¿failuremsg¿.¿ did hard shut down and the surgeon re-homed the robot.Went into rio setup and still got the error.Product history review a review of the dhr associated with (b)(4) found quality inspection procedures successfully passed.Complaint history review a review of complaints in catsweb and trackwise related to p/n 209999, serial number (b)(4) shows no additional complaints related to the failure in this investigation.Conclusions: shut down the robot completely again, rehomed the robot, and we were able to successfully complete rio setup and rio registration and the case was completed successfully.Following hard reboot no subsequent issues were reported related to this event.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

On thursday, (b)(6) 2017, i was attempting to do rio setup for right tka with surgical tech but continuously got error ¿burr mismatch¿.There was also a message on the screen to release the trigger on the handpiece, however the trigger on the mics was not being pressed.Reset arm software, reset cutter, and did soft reboot but still got the same error.Swapped out the mics handpiece and the same thing happened, ¿burr mismatch error¿.Went to mics status check and got error ¿reference to non-existenet field ¿failuremsg¿.¿ did hard shut down and the surgeon re-homed the robot.Went into rio setup and still got the error.Shut down the robot completely again, rehomed the robot, and we were able to successfully complete rio setup and rio registration and the case was completed successfully.Surgical delay of less than 30 minutes.Files uploaded in the complaints folder (b)(4).

• 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 Key: 7151169
• MDR Text Key: 96345602
• Report Number: 3005985723-2017-00652
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• PMA/PMN Number: K170581
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 03/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 209999
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization