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	01/30/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The following information was provided: cup was placed superior to plan and at 20 degrees of inclination, planned inclination was 40 degrees.Case type / application: tha 4.1.
Additional Manufacturer Narrative
Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There has been similar event(s) for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
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: the incorrect cup inclination cannot be attributed to a single definitive root cause.The available workflow data indicates several factors that may have influenced cup orientation, including sub-optimal pelvic registration capture, incomplete lowering of the robotic arm during reaming and impaction, and base array positioning in a lower-accuracy region of the camera field.A deep acetabular ream was also recorded, which would not directly affect inclination but may influence the superior position of the cup.Pre-surgery checks and service records indicate that the system was cleared for use prior to the surgery date and was cleared for clinical use on the day of and after the date of surgery.Clinician review: no medical records were received for review with a clinical consultant.Product history review: a review of device history records shows that product was inspected and the quality inspection procedures were completed with no reported discrepancies.Complaint history review: a review of complaints in trackwise related to product shows 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.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.
Event or Problem Description
No new information.

• 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 ; 2018315000
• MDR Report Key: 24405519
• Report Number: 3005985723-2026-00094
• Device Sequence Number: 8299824
• Product Code: OLO
• UDI-Device Identifier: 07613327395280
• UDI-Public: 07613327395280
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 03/31/2026

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?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/30/2026
• Supplement Date Received by Manufacturer: 03/03/2026
• Initial Report FDA Received Date: 02/20/2026
• Supplement Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/09/2023
• 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: Unknown