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

Model Number	109343
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for evaluation.Upon inspection the trigger was removed, and the spring clip was observed to be bent.The deformation of the trigger spring clip caused increased downward force on the trigger, resulting in the friction and interference between components.This mechanical interference could prevent the trigger from returning to its natural position, leading to the reported jamming.The observed condition is consistent with the reported event.The surgery was completed without complication, and no injuries were reported.
Event or Problem Description
During insertion of distal femoral pins, the surgeon reported that the mini trigger was stuck in the activated position and would not return to the off position as expected.The jammed tmini trigger could result in unintended spinning of the pin, which presents a potential risk of user or patient injury due to loss of control of the pin or unintended tissue contact.The procedure was completed using the tmini system, and no injury to the patient or user was reported.

• Brand Name: TMINI MINIATURE ROBOTIC SYSTEM
• Common Device Name: ORTHOPEDIC STERIOTAXIC INSTRUMENT
• Manufacturer (Section D): THINK SURGICAL, INC; 47201 lakeview blvd; fremont CA 94538
• Manufacturer (Section G): THINK SURGICAL; 47201 lakeview blvd; fremont CA 94538
• Manufacturer Contact: denise duchene ; 47201 lakeview blvd; fremont, CA 94538 ; 8604815113
• MDR Report Key: 23796494
• Report Number: 3000719653-2025-00020
• Device Sequence Number: 10493949
• Product Code: OLO
• UDI-Device Identifier: M9461093430
• UDI-Public: M9461093430
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K252544
• 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): 12/12/2025

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
• 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: 11/17/2025
• Initial Report FDA Received Date: 12/12/2025
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown