MAUDE Adverse Event Report: MAKO SURGICAL CORP. 3.0 RIO ROBOTIC ARM - MICS; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number	209999
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	03/07/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As part of normal complaint follow-up, an evaluation of the event has been initiated by mako surgical.A supplemental report will be submitted if additional information becomes available.
Event or Problem Description
During mako case, the knee was looser than planned (showing 3deg ext during trialing and implantation.Therefore, checked cuts and noticed deep tibial cut(1.3mm) and deep distal femoral cut (0.8).Trial and implant fit was good but resulted in surgeon putting in a thicker poly insert 11mm and some hyperextension (3 deg).Lot numbers below.Green probe 0.3, blue probe 1.0.Robot reg good, verification 0.39.
Additional Manufacturer Narrative
Reported event: an event regarding inaccurate resection involving a mako tka software was reported.The event was not confirmed because the product was not available for inspection.Method & results: -product evaluation and results: review of the case session files was not performed as case session data was not provided.-clinician review: no medical records were received for review with a clinical consultant.-product history review: a review of device history records shows that rob230 was inspected and the quality inspection procedures were completed with no reported discrepancies -complaint history review: a review of complaints shows other similar complaints for tka software - inaccurate resection.Conclusions: the alleged failure mode cannot be confirmed because the relevant log files and session files were not provided for inspection.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: 3.0 RIO ROBOTIC ARM - MICS
• 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: 21755733
• Report Number: 3005985723-2025-00129
• Device Sequence Number: 18192907
• Product Code: OLO
• UDI-Device Identifier: 00848486030407
• UDI-Public: 00848486030407
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 06/04/2025

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: 209999
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/07/2025
• Supplement Date Received by Manufacturer: 05/14/2025
• Initial Report FDA Received Date: 04/02/2025
• Supplement Report FDA Received Date: 06/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/10/2012
• 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 Age: 67 YR
• Patient Sex: Male