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	10/31/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The following was reported: "mps reported that the robot is not passing rio verification, after troubleshooting, it passed but cuts were inaccurate.Mps replaced all the instruments and the mics.Distal cut was deep by 4 mm.Surgeon had to cement the implant.".
Event or Problem Description
No new information.
Additional Manufacturer Narrative
An event regarding inaccurate resection involving a mako robotic arm was reported.The event was not confirmed.Method & results: -product evaluation and results: the field service engineer reported: troubleshooting notes: mps replaced all the instruments and the mics.Surgeon had to cement the implant; no augment was used.Work performed: observation, attempted reproduction of knee software verification issues on both sides of the robot and could not with fse supplied mics and arrays.Action taken, replaced camera as a precaution as the mount was unstable.Advised mps to replace all arrays and mics and to begin tracking verification issues per lot number.Performed pm as a precaution as well.System passed all testing per service manual.System ready for clinical use.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: there have been no other complaints with similar event(s) for the lot referenced.Conclusions: the alleged failure mode was not confirmed.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: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 23659983
• Report Number: 3005985723-2025-00553
• Device Sequence Number: 10124155
• Product Code: OLO
• UDI-Device Identifier: 07613327395280
• UDI-Public: 07613327395280
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 03/27/2026

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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/31/2025
• Supplement Date Received by Manufacturer: 02/26/2026
• Initial Report FDA Received Date: 11/26/2025
• Supplement Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/24/2009
• 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