TMINI™ Navigation Console 108757Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI M9461087570), received between Aug 28, 2024 and Feb 6, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Communication or Transmission Problem” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 6, 2026Insufficient Device Problem Information; Data Problem

  THE SURGEON REQUESTED A POSTERIOR REFERENCING PLAN; HOWEVER, AN ANTERIOR REFERENCING PLAN WAS UPLOADED FOR THE PROCEDURE. THE DISCREPANCY WAS IDENTIFIED PRIOR TO THE PROCEDURE DURING THE CONFIRMATION OF INSTRUMENTS SCREEN ON THE TMINI NAVIGATION CONSOLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24280655 ↗
• MalfunctionMay 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SURGEON REPORTED FEMORAL NOTCHING WAS OBSERVED ON THE POST-OP X-RAY. THE SURGEON STATED THAT A NOTCH WARNING APPEARED ON SCREEN DURING GAP ASSESSMENT BUT WAS RESOLVED AFTER MAKING NECESSARY FEMORAL IMPLANT POSITION ADJUSTMENTS. HE NOTED THAT AFTER SAVING THE ADJUSTMENTS, THE EXPECTED CONFIRMATION SCREEN DID NOT APPEAR. THE CASE WAS COMPLETED ROBOTICALLY, AND A VISIBLE FEMORAL NOTCH WAS OBSERVED AFTER COMPLETING THE 4-IN-1 FEMORAL CUTS. THE NOTCH WAS CONSEQUENTLY CONFIRMED WITH THE POST-OP X-RAY.

  Patient problems: Bone Notching

  MAUDE report 22119531 ↗
• MalfunctionMar 26, 2025Communication or Transmission Problem; Communication or Transmission Problem

  THE SURGEON REVIEWED THE SURGICAL PLAN DURING THE PROCEDURE AND MODIFIED THE POSITIONING OF THE FEMORAL COMPONENT. AFTER COMPLETING THE FEMORAL CUTS, THE SURGEON USED A CALIPER TO VERIFY THE CUTS BEFORE PROCEEDING WITH THE TIBIAL CUTS. ONCE THE FLEXION AND EXTENSION GAPS WERE CAPTURED, THE SURGEON ADJUSTED THE POSITIONING OF THE TIBIAL COMPONENT TO BALANCE THE GAPS. THE TIBIAL PINS WERE THEN PLACED CLOSER TOGETHER. AFTER FINISHING THE TIBIAL CUTS AND VERIFYING THEM WITH A CALIPER, IT WAS OBSERVED THAT THE ALIGNMENT APPEARED VALGUS RATHER THAN THE PLANNED VARUS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21702595 ↗
• MalfunctionAug 28, 2024Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT DURING SURGERY,THAT THE DISTAL MEDIAL RESECTION WAS LARGER THAN PLANNED. AS A RESULT IT APPERED 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 20092780 ↗

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