MAUDE Adverse Event Report: THINK SURGICAL, INC TMINI MINIATURE ROBOTIC SYSTEM; ORTHOPEDIC STEROTAXIC INSTRUMENT

Model Number	108757
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Notching (4890)
Date of Event	04/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The surgeon reported femoral notching was observed on the post-op x-ray.The surgeon stated that a notch warning appeared on screen during gap assessment but was resolved after making necessary femoral implant position adjustments.He noted that after saving the adjustments, the expected confirmation screen did not appear.The case was completed robotically, and a visible femoral notch was observed after completing the 4-in-1 femoral cuts.The notch was consequently confirmed with the post-op x-ray.
Additional Manufacturer Narrative
A surgeon reported the presence of a femoral notch observed on a postoperative x-ray following a robot-assisted total knee arthroplasty.A technical investigation was performed, including review of the tnav system log files.The logs confirmed that the final implant plan was properly confirmed and transferred to the robotic cutting system (tmini).The predicted anterior notch in the plan was minimal (approx.0.9 mm) a warning is presented to the user for notches above 1mm, and there was no log evidence of a larger notch being planned or presented.Registration confidence was within acceptable limits throughout the case.The software functioned as intended during plan finalization and data transfer; however, the reported absence of a confirmation screen may indicate a potential user interface anomaly.Although the system did not present a plan with a 5 mm notch, a deeper than expected notch occurred during resection.The instrumentation used during the manual portion of the procedure (improper placement of cutting guide, excessive saw angulation, or manual cuts) can lead to femoral notching.As of the date of this report, no adverse patient outcomes or medical interventions have been reported.Nonetheless, due to the potential user interface anomaly and the presence of a postoperative condition (femoral notch) think surgical decided to report this event.

• Brand Name: TMINI MINIATURE ROBOTIC SYSTEM
• Common Device Name: ORTHOPEDIC STEROTAXIC INSTRUMENT
• Manufacturer (Section D): THINK SURGICAL, INC; 47201 lakeview blvd; fremont CA 94538
• Manufacturer (Section G): THINK SURGICAL, INC; 47201 lakeview blvd; fremont CA 94538
• Manufacturer Contact: denise duchene ; 47201 lakeview blvd; fremont, CA 94538 ; 8604815113
• MDR Report Key: 22119531
• Report Number: 3000719653-2025-00005
• Device Sequence Number: 11789647
• Product Code: OLO
• UDI-Device Identifier: M9461087570
• UDI-Public: M9461087570
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K243285
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/30/2025

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 Model Number: 108757
• Device Catalogue Number: 108757
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2025
• Initial Report FDA Received Date: 05/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown