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

Model Number	109343
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Notching (4890)
Date of Event	01/12/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event is under investigation to determine the cause of the reported femoral notching.The investigation will assess whether factors such as surgical planning or device use may have contributed.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
Femoral notching was observed during a system demo conducted on a cadaver.
Event or Problem Description
Femoral notching was observed during a system demo conducted on a cadaver.
Additional Manufacturer Narrative
This supplemental report summarizes the results of the manufacturer's investigation into a reported femoral notching event observed during a sales demonstration procedure.The investigation included review of pre-operative ct imaging, segmentation outputs, and surgical planning parameters.These data did not indicate the presence of femoral notching in the planned resections.The patient anatomy and bone quality were assessed as typical for the procedure, and segmentation was determined to be appropriately aligned with the anterior cortex.An independent verification of the registration algorithm was conducted using intra-operative landmark data collected during the procedure.Independently calculated transforms demonstrated close agreement with system-generated values, supporting expected performance of the registration subsystem.Intra-operative system log data were reviewed.The femoral component was evaluated across multiple positions, with calculated notching values ranging from 0.29 mm to 2.06 mm and a final value of 0.38 mm.This final value is below the 1 mm threshold required to trigger a system-generated notching warning.Review of the intra-operative plan confirmed that no femoral notching was present in the plan transferred to the robotic system.Device performance was further assessed through system log review.No tmini system or tracking-related faults or error codes were identified.The surgical plan was successfully transferred from the tnav system to the robotic system.Pin placement accuracy was evaluated using system data and demonstrated less than 0.5° deviation in flexion and extension relative to the planned orientation.The reporter indicated that a femoral notch was observed following execution of the anterior bone resection using the 4-in-1 guide.The reporter also stated that the distal femoral resection was verified as accurate and that only the anterior cut was affected.However, no objective supporting documentation (e.G., quantitative measurements, intra-operative photographs, or post-operative imaging) was provided to substantiate the reported observation.The absence of this information limits the ability to independently confirm the reported condition.A review of risk management documentation identified known use-related risks associated with femoral notching, including potential misinterpretation of planning parameters, selection of incorrect resection or alignment values, and other user-dependent factors.Implemented risk control measures, including visualization of resection parameters, system feedback on plan adjustments, and required user confirmation of intra-operative changes, were verified to function as intended based on system design and testing.Additional testing was conducted to evaluate the reported absence of a notching warning during the procedure.The observed behavior could not be reproduced.Testing confirmed that the notching warning appears and clears dynamically when calculated values cross the defined threshold.Based on the available data, the investigation did not identify evidence of a device malfunction, software anomaly, planning error, registration error, or deviation in robotic-guided pin placement that would explain the reported event.However, due to the lack of objective clinical evidence and the manual nature of the bone resection step, the reported femoral notching could not be independently confirmed, and a definitive root cause could not be determined.

• 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: jason erickson ; 47201 lakeview blvd; fremont, CA 94538 ; 7077044558
• MDR Report Key: 24280654
• Report Number: 3000719653-2026-00004
• Device Sequence Number: 8365581
• Product Code: OLO
• UDI-Device Identifier: M9461093430
• UDI-Public: M9461093430
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K253661
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative,Distributor
• Initial Reporter Occupation: 505
• 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: 109343
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2026
• Supplement Date Received by Manufacturer: 01/12/2026
• Initial Report FDA Received Date: 02/06/2026
• Supplement Report FDA Received Date: 04/13/2026
• 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