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	07/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Encountered discrepancy between cuts made and final prosthesis position.Case type: tka 2.0.Anterior chamfer cuts were deeper than planned - cut discrepancy was angle 0 degree, 4mm.Planar probe was used to measure cut accuracy.
Additional Manufacturer Narrative
Reported event an event regarding inaccurate resection involving a mako robotic arm was reported.The event was confirmed.Method & results -product evaluation and results: the field service engineer reported: problem reproduced? yes trouble shooting notes: none work performed: mps encounters discrepancy between cuts made and final prosthesis position.Problem reproduced.Performed j2 bump stops, j5 encoder read head, j5-j6-j1-j4-j2 plastic covers, led brake release, j5 screw, j4 cover, ndi camera, and ss2u computer replacement.Robotic arm encoder signal quality control performed, optimized values for j2, m4, m5, and m6 axes.The system passed the complete matrix test.The results of the cutting tests performed on the system are equivalent to those obtained with the demo system.The patient data hard disk was delivered to the customer.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 robot was inspected with no reported discrepancies -complaint history review: a review of complaints in trackwise shows no other complaints related to the failure in this investigation.Conclusions: the alleged failure mode was confirmed to be due to accuracy issues with the encoder, bump stop, ss2u computer and camera as per the field service engineer visit.Based on the information reviewed there is no indication of any inherent software issue.No additional investigation or specific actions are required.If additional information is received, then the complaint will be reopened.
Event or Problem Description
No new information.

• 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: 22716277
• Report Number: 3005985723-2025-00358
• Device Sequence Number: 9577413
• Product Code: OLO
• UDI-Device Identifier: 00848486030407
• UDI-Public: 00848486030407
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 10/28/2025

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): Follow-Up
• Initial Date Received by Manufacturer: 07/11/2025
• Supplement Date Received by Manufacturer: 09/30/2025
• Initial Report FDA Received Date: 08/05/2025
• Supplement Report FDA Received Date: 10/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/24/2011
• 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: Male