MAUDE Adverse Event Report: MAKO SURGICAL CORP. MAKO ROBOTIC ARM 3.1; Orthopedic Stereotaxic Instrument

Catalog Number	219999
Medical Device Problem Codes	Application Program Problem: Parameter Calculation Error (1449); 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
The following information was provided: this is for case 1 of 3.Surgeon is requesting service due to all inclination and version values were reading incorrectly for all 3 cases today.Currently only known for left side cases.Pre-surgery was green, changed angle of the arm, and rotate arm.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
An event regarding inaccurate values/ visuals 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.Troubleshooting notes: pre-surgery was green, changed angle of the arm, and rotate arm.Work performed: surgeon is requesting service due to all inclination and version values were reading incorrectly for all 3 cases today.Currently only known for left side cases.During investigation, fse removed all service panels to begin a visual inspection of the system and fse immediately found that a plastic drape was caught in j2 motor pinion and j2 transmission cable causing drag in the joint and joint instability.Fse removed all plastic pieces caught in the joint and thoroughly cleaned the entire area of any plastic pieces allowing j2 to move freely with no further issues.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: 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 no other complaints with similar event(s) for the lot referenced.Conclusions: the alleged failure mode was confirmed to be potentially caused by hardware related failure mode ¿ ¿plastic drape was caught in j2 motor pinion and j2 transmission cable causing drag in the joint and joint instability¿ 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.

• 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: sanjana talathi ; 325 corporate drive; mahwah, NJ 07430 ; +1(201)831-5000
• MDR Report Key: 25320020
• Report Number: 3005985723-2026-00270
• Device Sequence Number: 5254773
• Product Code: OLO
• UDI-Device Identifier: 07613327395280
• UDI-Public: 07613327395280
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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
• Was Device Available for Evaluation?: Yes
• 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: 08/27/2026
• Initial Report FDA Received Date: 05/28/2026
• Supplement Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/21/2022
• 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