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); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An event regarding unintended movement involving a mako robotic arm was reported.The event was not confirmed.Method & results: product evaluation and results: the field service engineer reported: problem reproduced: no troubleshooting notes: surgeon requesting service, he says that it feels like he has to lift the arm more to keep it on plane while cutting, it felt like it was heavier, the gravity was off from what he is used to work performed: mps reported surgeon request for surgeon request for service regarding weight of the arm while cutting.During investigation, moved the arm to multiple positions to verify that the arm could support it's own weight without a load (instrument) attached to the arm.Checked in various locations on both left & right sides of the system with no issues.Performed a full saw bone test once on both left & right side of the system with no issues.Could not replicate issue.As a pre-caution, fse performed full find arm gravity constants on the system and then performed another saw bone test on the system with no issues.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 not confirmed.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.
Event or Problem Description
Surgeon requesting service, he says that it feels like he has to lift the arm more to keep it on plane while cutting, it felt like it was heavier, the gravity was off from what he is used to.
Event or Problem Description
Surgeon requesting service, he says that it feels like he has to lift the arm more to keep it on plane while cutting, it felt like it was heavier, the gravity was off from what he is used to.
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.

• 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: alessandra chavez ; 3365 enterprise ave; weston, FL 33331 ; 9546280700
• MDR Report Key: 21080881
• Report Number: 3005985723-2025-00003
• Device Sequence Number: 18226196
• Product Code: OLO
• UDI-Device Identifier: 00848486030407
• UDI-Public: 00848486030407
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 03/24/2025

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/12/2024
• Supplement Date Received by Manufacturer: 02/28/2025
• Initial Report FDA Received Date: 01/06/2025
• Supplement Report FDA Received Date: 03/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/25/2014
• 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