MAUDE Adverse Event Report: MAKO SURGICAL CORP. MAKO ROBOTIC ARM 3.1; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number	219999
Medical Device Problem Codes	Positioning Problem (3009); Unintended Movement (3026)
Health Effect - Clinical Code	Muscle/Tendon Damage (4532)
Date of Event	01/08/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The following information was provided: the robotic arm dropped when the surgeon moved it to align the anterior plane, causing the saw to damage the patient¿s muscle and skin.The surgeon had not triggered the mics yet.The mps pressed the e-stop and moved the robot out of the patient, then clicked ¿continue¿ on the screen.After that, the mps moved the robot back in and continued the case.Update from call with mps - (b)(6): 1.Experienced surgeon (5year mako user, 500+ cases), stated that he was thailand¿s proctor surgeon, experienced surgeon who observes and evaluates other surgeons.2.The arm dropping caused a puncture into the patients vastus medialis muscle causing a partial tear, stated 5mm 3.Mentioned 10-15 min delay, total delay for a mako recheck before recommencing with the case and for the suture repair.4.The robotic arm dropped at beginning of the case before any cuts were made.5.Thailand team looking to see if this occurred previously.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
Reported event an event regarding unintended movement involving a mako tka software was reported.The event was confirmed.Method & results product evaluation and results: investigation and root cause to be assessed under nc.Clinician review: no medical records were received for review with a clinical consultant.Product history review: a review of device history records shows that rob1470 was inspected and the quality inspection procedures were completed with no reported discrepancies.Complaint history review: a review of complaints in trackwise related to p/n 219999, robot number: rob1470 shows no other similar complaints for tka software - unintended movement.Conclusions: the alleged failure mode was confirmed.Investigation and root cause will be further assessed under nc.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: alessandra chavez ; 3365 enterprise ave; weston, FL 33331 ; 9546280700
• MDR Report Key: 24277105
• Report Number: 3005985723-2026-00053
• Device Sequence Number: 8580309
• Product Code: OLO
• UDI-Device Identifier: 07613327395280
• UDI-Public: 07613327395280
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 01/08/2026
• Supplement Date Received by Manufacturer: 02/20/2026
• Initial Report FDA Received Date: 02/06/2026
• Supplement Report FDA Received Date: 03/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female