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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
System logs confirm that registration was completed correctly and without error.During the procedure, the surgeon encountered difficulty during pin insertion and used a mallet, which is standard in manual tka but can affect pin alignment in robotic-assisted procedures.The think surgical representative informed the surgeon that this technique could compromise the pin plane and, in turn, affect cut accuracy.In the second attempt, the medial pin was placed in the same location as the initial attempt, possibly due to spatial constraints in the operative field.Reusing the original pin hole, particularly if it had been altered during the initial placement, could contribute to persistent inaccuracy.Post-cut verification with the digitizer revealed a 2 mm deviation laterally.This is within the accuracy specifications of the tmini system, but the surgeon opted to manually adjust the cut using a saw.Final verification using both the digitizer and the gap assessment tool confirmed an accurate resection.No patient injury or adverse outcome was reported.The most probable root cause was technique-related - specifically, the use of a mallet for pin insertion and reuse of an altered pin hole, both of which may have contributed to minor deviation in the cut plane.
Event or Problem Description
During a total knee arthroplasty procedure using tmini system, the tibial cut appeared to deviate by approximately 2mm.The surgeon encountered resistance during pin insertion and used mallet to assist, as commonly done in manual tka procedures.A think surgical representative present at the time advised that using a mallet could impact the accuracy of the pin plane.Following the tibial cut, the surgeon verified resection using the digitizer and noted the lateral side was 3mm proud.After consulting with the think surgical representative, the surgeon decided to reposition the pins and perform a recut using the tmini system.The medial pin was inserted in the same hole as the previous placement, while the lateral pin was positioned in a new location.After the second cut, verification with the digitizer showed a 2mm discrepancy.The surgeon then manually adjusted the lateral side using a saw and verified the result using both the digitizer and the tmini gap assessment screen.The procedure was completed robotically without any reported patient harm.

• 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: 21971422
• Report Number: 3000719653-2025-00004
• Device Sequence Number: 18268533
• Product Code: OLO
• UDI-Device Identifier: M9461093430
• UDI-Public: M9461093430
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 05/06/2025

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2025
• Initial Report FDA Received Date: 05/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2024
• 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