MAUDE Adverse Event Report: MAKO SURGICAL CORP. MAKO 4 ROBOTIC ARM; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number	229999
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	05/22/2025
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
To mention, this is a mako hip with the 5.0 software.Everything in the case was going smooth until we got to impaction.The doctor manually inserted the cup to the desired position and then connected the robot.Where he thought 40/26 should be, was actually reading 40/50.When we adjusted the version to see the robots view of 26, the cup would have been super retroverted.
Additional Manufacturer Narrative
An event regarding inaccurate values/visuals involving a mako tha software was reported.The event was not confirmed because the product was not available for inspection.Method & results: product evaluation and results: review of the case session files was not performed as case session data was not provided.A request for a field service engineer inspection was not made and the robot was not inspected as no service max case & work order exists.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 cannot be determined because the relevant log files and case session files were not available for inspection.Additionally, there has been no onsite inspection by a field service engineer.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.
Event or Problem Description
No new information.

• Brand Name: MAKO 4 ROBOTIC ARM
• 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: 22199167
• Report Number: 3005985723-2025-00261
• Device Sequence Number: 12691367
• Product Code: OLO
• UDI-Device Identifier: 07613327624304
• UDI-Public: 07613327624304
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 09/01/2025

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: 229999
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/22/2025
• Supplement Date Received by Manufacturer: 08/07/2025
• Initial Report FDA Received Date: 06/12/2025
• Supplement Report FDA Received Date: 09/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/07/2024
• 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