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

Model Number	109343
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Bone Notching (4890)
Date of Event	01/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During the investigation, additional feedback recieved from clinical team, indicated the pins were manually manipulated using a mallet after placement, and the final pin placement was not confirmed before proceeding with the procedure.No serious harm to patient occurred, as confirmed by the surgeon.X-ray analysis, based on log file data, revealed a 3 degrees of rotational error in the femoral plane, and 1.4 mm anterior-posterior translational error from the final approved plan.This deviation resulted in a 5.9 mm difference in the notch depth compared to the planned values.A simulated analysis was conducted to assess whether 3 degree rotational error impacted registration.The simulation confirmed that such a rotational error would prevent the system from acheiving proper registration, supporting the conclusion that the root cause was unrelated to registration.The identified root cause is user error, specifically the manual manipulation of the pins with a mallet after placement and failure to confirm final pin placement before proceeding with the procedure.Additionally, inadequate training was noted, as the notch depth should have been communicated when nearing 1mm, and the surgeon should have been instructed against manually manipulating the pins.According to the accessories risk analysis, this situation was foreseen and documented as a risk with the potential harm classified as poor knematic outcome.The estimated residual risk has been minimized to the extent possible, and this risk is has been determined as acceptable according to tsi's risk acceptance criteria.
Event or Problem Description
Prior to making the 4-in-1 femoral resections, the surgeon performed the gap assessment workflow and did not change the size of the femur from the original approved plan.During execution of 4-in-1 resection steps, the surgeon observed notching of the anterior femoral cut.The case was completed robotically.

• 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: 21327678
• Report Number: 3000719653-2025-00002
• Device Sequence Number: 20799790
• Product Code: OLO
• UDI-Device Identifier: M9461093430
• UDI-Public: M9461093430
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 02/06/2025

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2025
• Initial Report FDA Received Date: 02/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/16/2024
• Is the Device Labeled for Single Use? (Y/N): No
• 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