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); Device Operates Differently Than Expected (2913)

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

Event Date 12/12/2016

Event Type  malfunction  

Event Description

The surgeon was completing a total knee arthroplasty procedure using the robotic arm interactive orthopedic system (rio) when a communication error occurred.The surgeon did not wait for the issue to be resolved.The surgeon proceeded with the case manually.

Manufacturer Narrative

Follow-up #1 and final report submitted to update mfr site info, date received by mfr, type of reports, if follow-up, what type?, device evaluated by mfr?, evaluation codes, additional mfr narrative based on the results of investigation.Reported event: the reported device is a 3.0 rio robotic arm - mics, catalog: 209999, serial #: (b)(4).Mps reported communication error.Device history: a review of the dhr associated with rio 462 found the pt review successfully passed.Device investigation: per gsp:140541.Fse was able to reproduce communication error.Guidance ethernet converter was replaced.System was able to establish a connection and all validation tests passed.System is ready for clinical use.Complaint history: based on the device identification (pn 209999) the complaint databases were reviewed from 2011 to present for similar reported events regarding rob462 getting a communication error.There were no other similar reported event for the referenced serial number.Conclusion: mps reported a communication error.Fse upon inspection reproduced communication error and replaced the ethernet converter.Communication was re-established and system passed all verification checks.System is ready for clinical use.Further action: none at this time.

Event Description

The surgeon was completing a total knee arthroplasty procedure using the robotic arm interactive orthopedic system (rio) when a communication error occurred.The surgeon did not wait for the issue to be resolved.The surgeon proceeded with the case manually.

• 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: 6241363
• MDR Text Key: 64582997
• Report Number: 3005985723-2017-00012
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143752
• 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: 02/13/2017

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 Number: 209999
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/13/2016
• Initial Date FDA Received: 01/11/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/13/2017
• 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