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 11/22/2016

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

When the surgeon was completing a partial knee arthroplasty procedure using the robotic arm interactive orthopedic system (rio), an error message occurred and pre-surgery had to be repeated.The surgeon opted to cancel the case.The patient was under anesthesia.

Manufacturer Narrative

Reported event: the reported device is a 3.0 rio® robotic arm - mics, catalog: 209999, s/n: (b)(4).Mps received what appeared to be a connection error.Device history: a review of the dhr associated with rio 348 found quality inspection procedures successfully passed.Device investigation: per gsp 139643.Mps reported error message when opening pka.Error message stated to hit e-brake and enable button.Mps also stated a cutter warning was present before service.The error could not be reproduced during service and all tests passed.Mps was advised to use a voltage quality recorder to measure voltage during the next 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.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 of an error saying press e-button.There have been no other events for the serial number referenced, (b)(4).Conclusion: during a case the mps received a communication/hardware error after performing rio registration.Fse was unable to reproduce the error in the field and all v&v tests passed.It was recommended that the hospital outlets be cleaned and a voltage recorder be used during the next demo to test system voltages.System is ready for clinical use.Further action: none at this time.

Event Description

When the surgeon was completing a partial knee arthroplasty procedure using the robotic arm interactive orthopedic system (rio), an error message occurred and pre-surgery had to be repeated.The surgeon opted to cancel the case.The patient was under anesthesia.

• 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: 6131299
• MDR Text Key: 60993105
• Report Number: 3005985723-2016-00400
• 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: 11/22/2016
• Initial Date FDA Received: 11/29/2016
• 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