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

Model Number	109000
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The tnav cart prompts the surgeon to confirm the selected implant and plan prior to use; however, the anterior referencing plan was uploaded despite the surgeon's request for posterior referencing.The event remains under investigation to determine the cause, including whether the discrepancy was related to plan selection, review, or confirmation step.A follow-up report will be submitted upon completion of the investigation.
Event or Problem Description
The surgeon requested a posterior referencing plan; however, the plan uploaded for the procedure was anterior referencing.This discrepancy was not identified prior to the procedure and was discovered intraoperatively when the pins were being placed.
Additional Manufacturer Narrative
This supplemental report summarizes the results of the manufacturer's investigation into a reported discrepancy between the planned implant and instrumentation used during the procedure.The case was initially planned in (b)(6) 2025 using a zimmer biomet m01 posterior referencing implant for a procedure that was later cancelled and rescheduled for (b)(6) , 2025.In (b)(6) 2025, the tplan and tnav systems at the user facility were upgraded to include zimmer biomet m02 implant modules.On (b)(6) , 2025, the case was replanned onsite.When the original m01 plan was opened on a system configured with only m02 implants, the system indicated the implant was unavailable and initiated replanning.During this process, the implant family defaulted to an anterior referencing configuration, although this selection remained user-editable, and the plan was reviewed and approved accordingly.On (b)(6) , 2025, the anterior referencing plan was loaded into tnav, while posterior referencing instrumentation was present in the operating room.The mismatch was identified intraoperatively prior to placement of the 4-in-1 guide block pins, and the procedure did not progress to robotic-assisted pin placement with the tmini system.No patient harm was reported.The investigation included review of system logs, software behavior, and user workflow.The tplan system was observed to automatically populate the implant family field during replanning under these conditions, which differs from expected behavior where no default selection should occur.Testing confirmed that users could modify the implant selection prior to plan approval.Risk management documentation identifies risks related to incorrect implant selection and use of incorrect referencing instrumentation.Existing controls include user confirmation steps and tnav interface prompts displaying implant type and guiding instrumentation selection.These controls were present and functional, and the discrepancy was identified prior to execution of the robotic-assisted portion of the procedure.Based on the available information, the event was associated with a mismatch between the planned implant and available instrumentation.Contributing factors include system behavior during replanning and user-dependent review and confirmation of implant parameters.No device malfunction or unintended robotic system performance was identified, and the root cause cannot be definitively attributed to a single factor.
Event or Problem Description
The surgeon requested a posterior referencing plan; however, the plan uploaded for the procedure was anterior referencing.This discrepancy was not identified prior to the procedure and was discovered intraoperatively when the pins were being placed.

• 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, INC; 47201 lakeview blvd; fremont CA 94538
• Manufacturer Contact: jason erickson ; 47201 lakeview blvd; fremont, CA 94538 ; 7077044558
• MDR Report Key: 24096856
• Report Number: 3000719653-2026-00001
• Device Sequence Number: 10296205
• Product Code: OLO
• UDI-Device Identifier: M9461090000
• UDI-Public: M9461090000
• 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,Followup
• Report Date (Section B): 04/13/2026

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: 109000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2025
• Supplement Date Received by Manufacturer: 12/16/2025
• Initial Report FDA Received Date: 01/16/2026
• Supplement Report FDA Received Date: 04/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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