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 03/20/2017

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

The surgeon was completing a total knee arthroplasty procedure using the robotic arm interactive orthopedic system.The mics hand piece began to shake and pulse.This happened while attempting to make the posterior chamfer cut.After shaking and pulsing for about ten to fifteen seconds it would shut off and show and error for angle inconsistency.Dr.(b)(6) was able to make both the distal femur and the tibia cut to beforehand this began.After about fifteen minutes of trouble shooting and repositioning the robot dr.(b)(6) choose to convert to manual instrumentation.

Manufacturer Narrative

(b)(4).Device investigation: the reported device was confirmed to be a 3.0 rio® robotic arm - mics, p/n 209999, lot rob311.Device history review: review of the device history records indicate 1 devices were manufactured and accepted into final stock on 12/10/14.No non-conformances were identified during inspection.Device evaluation and results: per fse the 3.0 rio® robotic arm - mics, p/n 209999, lot rob311 with a mics handpiece began to shake and pulse during a posterior chamfer cut.The pulsing motion would resulted in an angle inconsistency error.The fse attempted trouble shooting and repositioning the arm during a case but ultimately the physician choose to convert the case to manual instrumentation resulting in about a 15-20 minute delay.Per fse the vibration issue was duplicated and addressed by "making adjustments to j5 while monitoring the transmission and friction results of j5 and all other joints".The physician sampled the 3.0 rio® robotic arm - mics, p/n 209999, lot rob311 after the adjustments and deemed the results acceptable.System is ready for continued surgical use.Complaint history review: a review of complaints in (b)(6) related to p/n 209999, lot number rob311 shows no additional complaints related to the failure in this investigation.Conclusions: the failure was confirmed by the fse and repaired on site.System is ready for use.Corrective action/preventive action: none at this time.

Event Description

The surgeon was completing a total knee arthroplasty procedure using the robotic arm interactive orthopedic system.The mics hand piece began to shake and pulse.This happened while attempting to make the posterior chamfer cut.After shaking and pulsing for about ten to fifteen seconds it would shut off and show and error for angle inconsistency.Dr.(b)(6) was able to make both the distal femur and the tibia cut to beforehand this began.After about fifteen minutes of trouble shooting and repositioning the robot dr.(b)(6) choose to convert to manual instrumentation.

• 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
• 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: 6460285
• MDR Text Key: 71743124
• Report Number: 3005985723-2017-00166
• 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: 05/31/2017

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: 03/20/2017
• Initial Date FDA Received: 04/05/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/31/2017
• 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