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

Model Number	109343
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The user noticed pieces falling out of the tmini head during pre-op set-up of the product.Despite this, the tmini robot was used successfully.
Additional Manufacturer Narrative
Upon inspection of the returned tmini robot, think surgical, inc.Confirmed that one of the two the nut tubes was broken and the dowel pin was missing.The tmini functioned as intended as only one of the nut tubes was broken.Think surgical reviewed the device history record and confirmed there was no evidence of damage to the nut tube during production.There was no injury to patient, and the surgery was completed without complication using the tmini robot.However, think surgical is reporting this incident because if the dowel pin detached during the procedure, it could pose a risk of entering the surgical incision.

• 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: 23587185
• Report Number: 3000719653-2025-00018
• Device Sequence Number: 15767871
• Product Code: OLO
• UDI-Device Identifier: M9461093430
• UDI-Public: M9461093430
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/18/2025

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: 11/03/2025
• Initial Report FDA Received Date: 11/18/2025
• 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