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

Model Number	108757
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During a demonstration session (no patient involvement) a change to the surgical plan failed to transfer from the navigation console to the tmini robot.Analysis of the navigation console logs reveled the plan had been modified three times during surgery, but only two of the femoral changes were successfully transferred to the tmini robot.The third modification, which was related to the tibia, was confirmed but did not transfer to the tmini robot.This issue is related to a software anomaly that occurs when the following sequence of events happen during bone preparation: 1.The tmini robot is moved out of the optical communication range (field of view (fov)).2.Intraoperative changes are made to the plan on the navigation console.3.A change to the cut plane is made on the tmini robot using the 'select plane' button, while the robot is still out of fov.4.The tmini robot is brought back into fov to continue the procedure.In this scenario, the updated plan does not transfer from the navigation console to the tmini robot.The requirement to ensure proper plan transfer is documented in training and the instructions for use, which inform the user to keep the tmini robot in the fov until the plan transfers.
Event or Problem Description
The surgeon reviewed the surgical plan during the procedure and modified the positioning of the femoral component.After completing the femoral cuts, the surgeon used a caliper to verify the cuts before proceeding with the tibial cuts.Once the flexion and extension gaps were captured, the surgeon adjusted the positioning of the tibial component to balance the gaps.The tibial pins were then placed closer together.After finishing the tibial cuts and verifying them with a caliper, it was observed that the alignment appeared valgus rather than the planned varus.

• Brand Name: TMINI MINIATURE ROBOTIC SYSTEM
• Common Device Name: ORTHOPEDIC STEREOTAXIC 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: 21702595
• Report Number: 3000719653-2025-00003
• Device Sequence Number: 4682065
• Product Code: OLO
• UDI-Device Identifier: M9461087570
• UDI-Public: M9461087570
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/26/2025

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: 02/27/2025
• Initial Report FDA Received Date: 03/26/2025
• 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