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

Catalog Number	209999
Medical Device Problem Codes	Unintended System Motion (1430); Application Program Freezes or Fails to Launch (4031)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/23/2024
Type of Reportable Event	Malfunction
Additional 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 if additional information becomes available.
Event or Problem Description
The robotic arm shuts off during sawing due to velocity trap and off-plane warnings several times during each cut.It is not a smooth cut and has happened in several knees with multiple surgeons.It happens at least 3 times during every cut.It doesn¿t sound like smooth mechanics.Case type / application: tka 2.0.Mps reported that during cuts on the femur or tibia, the mics handpiece frequently loses power, causing the saw to stop.The arm also exhibits significant vibration and loud noise.These issues occur repeatedly, and the surgeon has requested immediate resolution.The problem has been ongoing for several weeks and has recently intensified.Mics status checks and mako registration pass with no issues.
Additional Manufacturer Narrative
An event regarding application freeze involving a mako robotic arm was reported.The event was confirmed.Method & results: -product evaluation and results: the field service engineer reported: troubleshooting notes: mics status checks and mako registration pass with no issues.Work performed: spoke to mps, he will create a new work order once rob is available for service.Work order disposition: system investigation completed successfully as per service manual.All system checks and tests passed; system is ready for use.Clinician review: no medical records were received for review with a clinical consultant.Product history review: review of the device history records indicate devices were 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 confirmed.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.
Event or Problem Description
The robotic arm shuts off during sawing due to velocity trap and off-plane warnings several times during each cut.It is not a smooth cut and has happened in several knees with multiple surgeons.It happens at least 3 times during every cut.It doesn't sound like smooth mechanics.Case type / application: tka 2.0.Mps reported that during cuts on the femur or tibia, the mics handpiece frequently loses power, causing the saw to stop.The arm also exhibits significant vibration and loud noise.These issues occur repeatedly, and the surgeon has requested immediate resolution.The problem has been ongoing for several weeks and has recently intensified.Mics status checks and mako registration pass with no issues.

• Brand Name: 3.0 RIO ROBOTIC ARM - 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: sanjana talathi ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 21147598
• Report Number: 3005985723-2025-00030
• Device Sequence Number: 13162466
• Product Code: OLO
• UDI-Device Identifier: 00848486030407
• UDI-Public: 00848486030407
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• 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): 03/30/2025

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: ROB211
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/23/2024
• Supplement Date Received by Manufacturer: 03/05/2025
• Initial Report FDA Received Date: 01/14/2025
• Supplement Report FDA Received Date: 03/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/02/2022
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown