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

Catalog Number	209999
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Mps reported inclination and offset incorrect in multiple cases.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
Reported event an event regarding inaccurate resection 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: rob069- mps reported inclination and offset incorrect in multiple cases work performed: cleaned cables and camera, performed pre surgery checks.Rio passed all required testing, rio is cleared for clinical use 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: a review of device history records shows that rob069 was inspected with no reported discrepancies.Complaint history review: there are other complaints with a similar failure mode for this lot conclusions: the alleged failure mode was not reproduced through an onsite inspection carried out by a field service engineer however the system was optimized for clinical use.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 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: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 23616129
• Report Number: 3005985723-2025-00542
• Device Sequence Number: 9072552
• Product Code: OLO
• UDI-Device Identifier: 00848486030407
• UDI-Public: 00848486030407
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 02/27/2026

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: ROB069
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/28/2025
• Supplement Date Received by Manufacturer: 02/27/2026
• Initial Report FDA Received Date: 11/21/2025
• Supplement Report FDA Received Date: 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/03/2009
• 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
• Patient Sex: Unknown