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

Model Number	109004
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon inspection of the returned tibial array, think surgical, inc.Confirmed that one screw securing the top of the case was loose.Examination of the screw and threaded hole revealed no damage, and a uv light inspection showed no evidence of adhesive residue.Think surgical contacted the array's supplier to verify whether loctite (thread locking adhesive) is used on this screw.The supplier confirmed that the loctite is not applied to the screw that secures the top case, although it is used on other screws within the assembly.The absence of the adhesive on this particular screw may have allowed it to loosen and fall out over time.There was no injury to patient, and the surgery was completed without complication using the tracking array.However, think surgical is reporting this incident because the screw detached during the procedure, and it could pose a risk of entering the surgical incision.
Event or Problem Description
The user noticed a screw fall out of the tibial array during tibial resection.Despite this, the screw was removed from the surgical field, and the array was used successfully during the procedure.

• 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: 23493182
• Report Number: 3000719653-2025-00015
• Device Sequence Number: 9106422
• Product Code: OLO
• UDI-Device Identifier: M9461090040
• UDI-Public: M9461090040
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K250877
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/04/2025

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: 109004
• 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: 10/07/2025
• Initial Report FDA Received Date: 11/06/2025
• 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