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

Catalog Number	209999
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
In a tha case, cup placement was alleged to be inaccurate.Position of the cup is not right and that it has no anteversion; we then did an intra op xray.Cup not in the right position (too far superior), visible overhang of cup.Inclination and version not as planned.
Additional Manufacturer Narrative
Reported event: an event regarding incorrect placement involving a mako tha software was reported.The event was confirmed.Method & results -product evaluation and results: review of the case session files noted the following: the final bone registration rms was 1.803 the limit for passing bone registration is an rms of 0.6.The user recaptured horn points 4 times.The posterior horn was good for all recaptures.The anterior was off for the 1st & 2nd landmark captures.The center of rotation was incorrect as well as the crest point and anterior notch for the pelvic bone registration.The user took 2 foveal points circled in red, and 8 proud and deep points circled in purple for the center of rotation.The distribution of points taken anteriorly intraoperatively did not match the pattern taken for the ct landmark center of rotation.The points were poorly taken with poor distribution anteriorly.6dof quality metric indicates 7 to 10 degrees of orientationally error in the bone registration.When the user notices that the system is giving good results (surgical results and on-screen visuals), but the physical bone does not match the virtual, there is a good chance that the bone registration is not correct especially if bone registration did not auto accept requiring user to manual verify.The user should try to match the pattern and location of the ct landmarks with those taken intraoperatively.Unrelated to cup placement, but something the user should note for future cases is that the femoral bone registration also failed.There is no indication of software or hardware error.The user chose to proceed with bone preparation with a failing bone registration.¿ clinician review: no medical records were received for review with a clinical consultant.Product history review: a review of the device history records show that the robot was inspected with no reported discrepancies.Complaint history review: a review of complaints in trackwise shows no other similar complaints for tha software - incorrect placement.Conclusions: based on the analysis of the relevant log files and session files, the alleged failure mode can be confirmed due to user error.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: 22770015
• Report Number: 3005985723-2025-00366
• Device Sequence Number: 9760238
• Product Code: OLO
• UDI-Device Identifier: 00848486030407
• UDI-Public: 00848486030407
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2025

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/16/2025
• Supplement Date Received by Manufacturer: 08/13/2025
• Initial Report FDA Received Date: 08/11/2025
• Supplement Report FDA Received Date: 09/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/15/2018
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown