MAUDE Adverse Event Report: MAKO SURGICAL ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM; STEROTAXIC INSTRUMENT

Model Number 201000

Device Problems Device Displays Incorrect Message (2591); Power Problem (3010)

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

Event Date 07/09/2014

Event Type  malfunction  

Event Description

The surgeon was performing a makoplasty partial knee arthroplasty using the robotic arm interactive orthopedic system (rio) and the restoris multicompartmental knee (mck) implant system.While the surgeon was resecting the femur, a low voltage battery warning appeared on the screen.The mako rep checked the power source code, but a few minutes later, the rio shut down completely.The rio was restarted, and upon homing, presented with a j6 error.Further attempts at troubleshooting were unsuccessful in eliminating the error.The surgeon chose to finish resecting the femur using the rio with the burr in override mode.The surgeon was not comfortable continuing with tibial resection, but did not feel that it was in the best interest of the patient to convert to a total knee nor to finish the case manually.The surgeon elected to leave the femoral trial in the patient's knee until field service could evaluate the rio system and then continue with the case later in the day.After the system was serviced, the patient was brought back into the o.R.And the surgeon completed the case successfully later that evening.

Manufacturer Narrative

As part of the normal complaint follow-up, an evaluation of the event has been completed at two mako surgical.Regarding the unexpected shutdown of the system, it was determined from the log files that the system was running with low voltage fro approximately 12 minutes.The system is designed to run on the backup power supply for approximately 5 minutes.The root cause of the low power situation was low voltage fluctuations.The o.R.Suite used at the hospital, and the o.R.Coordinators have designated the rio to run in a separate or room, which has improved power outlets.In addition, they will use power supply monitors for several cases to confirm that the low power scenario doe snot occur in the designated or.A make field service engineer (fse) visited the site to resolve the issue of the arm joint 6 locking up (j6 joint encoder index error).The fse successfully reproduced and corrected the issue, nad the rio passes testing.Lastly, the fse performed all tests as part of the service manual and released the system for clinical use.The case was completed after the field service assessment, with a successful outcome.

• Brand Name: ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM
• Type of Device: STEROTAXIC INSTRUMENT
• Manufacturer (Section D): MAKO SURGICAL; ft. lauderdale FL
• Manufacturer Contact: william tapia ; 2555 davie rd., suite 110; ft. lauderdale, FL 33317 ; 9546280605
• MDR Report Key: 4213674
• MDR Text Key: 17993278
• Report Number: 3005985723-2014-00097
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 201000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/09/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: RESTORIS MULTICOMPARTMENTAL KNEE (MCK) IMPLANT SYS
• Patient Age: 91 YR