MAUDE Adverse Event Report: MAKO Surgical Corp. MAKO ROBOTIC ARM 3.1; Orthopedic Stereotaxic Instrument

Catalog Number	219999
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	05/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Surgeon made changes to the tha plan prior to cases for the day.The case in question was the last case of the day (out of 5) and when we loaded the case back up nothing had changed.All of the surgeon numbers were just where we wanted them.When we went to ream the cup position was severely skewed and way off from the planned values, without us changing anything.Case type / application: tha 4.1.Update - there was likely an inclination/ version issue, however, the main concern was the superiorization of the ream vs the planned ream.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
An event regarding inaccurate reaming involving a mako robotic arm was reported.The event was not confirmed because the product was not available for inspection.Method & results: -product evaluation and results: a request for a field service engineer inspection was not made and the robot was not inspected as product was not available for inspection.-clinician review: no medical records were received for review with a clinical consultant.-product history review: review of the device history records indicate the reported device was manufactured and accepted into final stock with no 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 as there has been no onsite inspection by a field service engineer as product was not available for inspection.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: MAKO ROBOTIC ARM 3.1
• 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: deepan raju srinivasan ; 325 corporate drive; mahwah, NJ 07430 ; +1(201)831-5000
• MDR Report Key: 25518719
• Report Number: 3005985723-2026-00288
• Device Sequence Number: 15950967
• Product Code: OLO
• UDI-Device Identifier: 07613327395280
• UDI-Public: 07613327395280
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2026

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: 219999
• Device Lot Number: ROB2252
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/18/2026
• Supplement Date Received by Manufacturer: 08/26/2026
• Initial Report FDA Received Date: 06/16/2026
• Supplement Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/09/2023
• 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