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

Model Number	109343
Medical Device Problem Code	Unintended Power Up (1162)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The tmini robot was returned for evaluation.The surgical procedure was completed robotically without any delay or patient harm.A review of the system log filed did not reveal any reported errors or anomalies.The physical trigger mechanism was inspected and found to be intact, with normal movement and spring return.The device was tested using the standard tmini calibration and functional test, and the device behavior observed in the field could not be replicated during in-house evaluation.The device functioned as intended during all in-house testing.No additional corrective action is planned at this time.Although the event resulted in no patient harm and device functioned as intended during in-house evaluation, the reported behavior - unintended chuck actuation during surgery - could potentially lead to a delay or difficulty in the procedure if it were to recur; therefore, think surgical is submitting this medical device report.
Event or Problem Description
During surgery, it seemed like the tmini robot trigger mechanism was stuck.The pin was spinning when the robot was in the proper position (the device is designed to only spin the chuck when the head is on plane) even when the surgeon was not depressing the trigger button.

• 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: 22162757
• Report Number: 3000719653-2025-00006
• Device Sequence Number: 12633592
• Product Code: OLO
• UDI-Device Identifier: M9461093430
• UDI-Public: M9461093430
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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): 06/06/2025

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: 109343
• Device Catalogue Number: 109343
• 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: 04/22/2025
• Initial Report FDA Received Date: 06/07/2025
• 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