TMINI™ Robot 109343Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI M9461093430), received between Aug 28, 2024 and Feb 6, 2026 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K230202, K232802, K241031); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 6, 2026Adverse Event Without Identified Device or Use Problem

  FEMORAL NOTCHING WAS OBSERVED DURING A SYSTEM DEMO CONDUCTED ON A CADAVER.

  Patient problems: Bone Notching

  MAUDE report 24280654 ↗
• MalfunctionDec 12, 2025Material Deformation; Material Deformation

  DURING INSERTION OF DISTAL FEMORAL PINS, THE SURGEON REPORTED THAT THE MINI TRIGGER WAS STUCK IN THE ACTIVATED POSITION AND WOULD NOT RETURN TO THE OFF POSITION AS EXPECTED. THE JAMMED TMINI TRIGGER COULD RESULT IN UNINTENDED SPINNING OF THE PIN, WHICH PRESENTS A POTENTIAL RISK OF USER OR PATIENT INJURY DUE TO LOSS OF CONTROL OF THE PIN OR UNINTENDED TISSUE CONTACT. THE PROCEDURE WAS COMPLETED USING THE TMINI SYSTEM, AND NO INJURY TO THE PATIENT OR USER WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23796494 ↗
• MalfunctionNov 18, 2025Material Protrusion/Extrusion; Material Protrusion/Extrusion

  THE USER NOTICED A SMALL SILVER PIECE FALL OUT OF THE TMINI HEAD DURING STERILE SET-UP. DESPITE THIS, THE TMINI ROBOT WAS USED SUCCESSFULLY DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23587189 ↗
• MalfunctionNov 18, 2025Material Protrusion/Extrusion; Material Protrusion/Extrusion

  THE USER NOTICED PIECES FALLING OUT OF THE TMINI HEAD DURING PRE-OP SET-UP OF THE PRODUCT. DESPITE THIS, THE TMINI ROBOT WAS USED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23587185 ↗
• MalfunctionOct 8, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  ON 7/31/2025 THE THINK SURGICAL EMPLOYEE IDENTIFIED THAT THE TMINI PINS WERE NOT SPINNING INSIDE THE TMINI CHUCK. UPON INSPECTION, BLACK GREASE LIKE MATERIAL WAS OBSERVED ON THE END OF THE PIN THAT HAD BEEN IN THE CHUCK. THE TMINI SYSTEM WAS NOT USED, AND THE PATIENT WAS NOT EXPOSED AS THE ISSUE WAS DISCOVERED PRIOR TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23248720 ↗
• MalfunctionJun 7, 2025Unintended Power Up; Unintended Power Up

  DURING SURGERY, IT SEEMED LIKE THE TMINI ROBOT TRIGGER MECHANISM WAS STUCK. THE PIN WAS SPINNING WHEN THE ROBOT WAS IN THE PROPER POSITION (THE DEVICE IS DESIGNED TO ONLY SPIN THE CHUCK WHEN THE HEAD IS ON PLANE) EVEN WHEN THE SURGEON WAS NOT DEPRESSING THE TRIGGER BUTTON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22162757 ↗
• MalfunctionMay 6, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21971422 ↗
• MalfunctionFeb 6, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  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.

  Patient problems: Bone Notching

  MAUDE report 21327678 ↗
• MalfunctionJan 29, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  DURING A SURGICAL PROCEDURE OF THE LEFT KNEE, AFTER PERFORMING THE TIBIAL CUT WITH THE TMINI, THE SURGEON FEL THAT THE CUT WAS MORE VARUS THAN PLANNED AND THAT THE LATERAL TIBIAL RESECTION WAS "UNDER RESECTED" THE SURGEON THEN MANUALLY RESECTED MORE OF THE LATERAL PROXIMAL TIBIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21267316 ↗
• MalfunctionAug 28, 2024Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT DURING SURGERY THE LATERAL PIN WAS PLACED FURTHER INTO THE BONE TO ACCOUNT FOR THE PATIENT'S BONE QUALITY. AS A RESULT IT APPEARED THAT IMPLANT PLACEMENT WAS NOT CONSISTENT WITH THE APPROVED SURGICAL PLAN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 20092734 ↗
• MalfunctionAug 28, 2024Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT DURING SURGERY THE SURGEON NOTICED THAT THE FEMORAL BONE CUTS WERE NOT CONSISTENT WITH THE APPROVED SURGICAL PLAN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 20092714 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K230202, K232802, K241031. One submission often covers many models, so check the product and lot details in each record.

• Z-1318-2024 · Feb 12, 2024 · Open, Classified
  Assembly, Array Guide TMINI, REF: 109101, part of the TMINI Knee Instrument Set, used with the TMINI Miniature Robotic System