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

Catalog Number	219999
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Damage to Ligament(s) (1952); Muscle/Tendon Damage (4532)
Date of Event	11/07/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Partial injury to the medial collateral ligament during tibial osteotomy using mako.During the procedure, anchoring and suturing were performed.No additional treatment is planned.
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 because the product was not available for inspection.Method & results: product evaluation and results: 1.The relevant log files and case session files were not available for inspection.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 and the quality inspection procedures were completed 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 because the relevant log files and case session files were not available for inspection.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 ; 2018315000
• MDR Report Key: 23680491
• Report Number: 3005985723-2025-00564
• Device Sequence Number: 21293634
• Product Code: OLO
• UDI-Device Identifier: 07613327395280
• UDI-Public: 07613327395280
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2026

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?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/07/2025
• Supplement Date Received by Manufacturer: 02/24/2026
• Initial Report FDA Received Date: 12/01/2025
• Supplement Report FDA Received Date: 03/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/16/2024
• 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: Required Intervention
• Patient Sex: Unknown