MAUDE Adverse Event Report: MAKO SURGICAL CORP. 3.0 RIO® ROBOTICARM - MICS; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number	209999
Medical Device Problem Codes	No Visual Prompts/Feedback (4021); Application Program Freezes or Fails to Launch (4031)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Setup: cleaned cables before connecting, robot passed all pre surgery checks.Rio registration & intra op balancing: all normal.Left leg (pka) bone prep: - tibia floor & femur posterior cut (saw) - normal femur distal/ keel/pegs (burr) - normal.Tibia wall(burr)- froze.Surgeon aligned and started burring until midway the tibia wall, then the screen froze, but burr could still go on.Immediately told surgeon to release the trigger and to take the burr away from the patient.After few seconds from the trigger release, arm lock occurred.Keyboard no reaction to alt+prtscr+k.Little button on the back of the guidance module has response, waited 3 minutes but could not lead to software reboot.Decided to proceed with hard shut down.Went to e stop and brake release remove the arm even more away from the patient and put in holster position to facilitate homing later on.Hard shut down, turned on robot, deleted some plans, arm status check all green, homing, went back into case, continue burr.Tibia wall cut, in the model shows haven't burred anything, but before the screen froze, the model showed surgeon burred the anterior part already.Guided the surgeon to clean all the greens either way.No issues for the rest of the case.
Additional Manufacturer Narrative
As part of the 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 or Problem Description
Setup: cleaned cables before connecting, robot passed all pre surgery checks.Rio registration & intra op balancing: all normal.Left leg (pka) bone prep: - tibia floor & femur posterior cut (saw) - normal - femur distal/ keel/pegs (burr) - normal - tibia wall(burr)- froze - surgeon aligned and started burring until midway the tibia wall, then the screen froze, but burr could still go on.Immediately told surgeon to release the trigger and to take the burr away from the patient.After few seconds from the trigger release, arm lock occurred - keyboard no reaction to alt+prtscr+k.Little button on the back of the guidance module has response, waited 3 minutes but could not lead to software reboot.Decided to proceed with hard shut down.- went to e stop and brake release remove the arm even more away from the patient and put in holster position to facilitate homing later on.- hard shut down, turned on robot, deleted some plans, arm status check all green, homing, went back into case, continue burr - tibia wall cut, in the model shows haven't burred anything, but before the screen froze, the model showed surgeon burred the anterior part already.Guided the surgeon to clean all the greens either way.No issues for the rest of the case.
Additional Manufacturer Narrative
An event regarding application freeze involving a mako robotic arm was reported.The event was not confirmed because the product was not available for inspection.Method & results: -product evaluation and results: a request for a field service engineer inspection was not made and the robot was not inspected as no service max case & work order exists.-clinician review: no medical records were received for review with a clinical consultant.-product history review: review of the device history records indicate device was manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been other complaints with similar event(s) for the lot referenced.Conclusions: the alleged failure mode was not confirmed as there has been no onsite inspection by a field service engineer.If a field service inspection is requested, further investigation will be completed on this issue.Additionally, a complaint history review provides no indication of any inherent software/ hardware issue.No additional investigation or specific actions are required.If additional information is received, then the complaint will be reopened.

• Brand Name: 3.0 RIO® ROBOTICARM - MICS
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MAKO SURGICAL CORP.; 3365 enterprise ave; weston FL 33331
• Manufacturer (Section G): MAKO SURGICAL CORP.; 3365 enterprise ave; weston FL 33331
• Manufacturer Contact: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18281616
• Report Number: 3005985723-2023-00178
• Device Sequence Number: 6264432
• Product Code: OLO
• UDI-Device Identifier: 00848486030407
• UDI-Public: 00848486030407
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 209999
• Device Lot Number: ROB790
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/14/2023
• Supplement Date Received by Manufacturer: 03/11/2024
• Initial Report FDA Received Date: 12/07/2023
• Supplement Report FDA Received Date: 04/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/13/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 83 YR
• Patient Sex: Male