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

Catalog Number 209999

Device Problems Device Displays Incorrect Message (2591); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Discomfort (2330); No Known Impact Or Consequence To Patient (2692)

Event Date 11/23/2016

Event Type  Injury  

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

Prior to the surgeon was completing a partial knee arthroplasty procedure using the robotic arm interactive orthopedic system (rio), an error message displayed after opening the pka application.The patient was under anesthesia and woken up due to case being converted to a manual procedure.There was a case delay of 10-12 minutes.

Manufacturer Narrative

Reported event: an event regarding a reset cutter error occuring after opening the pka application involving 3.0 rio robotic arm - mics, catalog: 209999 was reported.Method & results: -device history review: a review of the dhr associated with rio 348 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 an error occuring after opening the pka application.There were no other reported events for the listed catalog number.Conclusion: a field service engineer went to visit the site (b)(4).Mps (b)(4) reported error message after opening pka application.Error message stated to hit e-brake and enable button.Error messages went away after following these instructions.Mps also stated a cutter warning was present before service.This error never presented itself during testing.A cutter test and burr status check was performed using each of the aspach motors and all tests passed.(b)(4) will follow up with a sawbone demo while using a voltage quality recorder to measure voltage during the demo.This information will be evaluated for any power irregularities.Medical center electricians will clean outlets used and ensure internal connections of the outlets are secure.System successfully passed all validation testing.Verified system is operating within mako tolerances and specifications.Attached all supporting documentation.System is ready for clinical use.

Event Description

Prior to the surgeon was completing a partial knee arthroplasty procedure using the robotic arm interactive orthopedic system (rio), an error message displayed after opening the pka application.The patient was under anesthesia and woken up due to case being converted to a manual procedure.There was a case delay of 10-12 minutes.

• 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
• 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 Key: 6146129
• MDR Text Key: 61471454
• Report Number: 3005985723-2016-00415
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112507
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 209999
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/23/2016
• Initial Date FDA Received: 12/05/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/23/2017
• 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 Number: 1
• Patient Outcome(s): Hospitalization