INTUITION 2525-45-400Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295545293), received between Nov 11, 2025 and Sep 22, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• MalfunctionSep 22, 2026Break

  It was reported that the UNI TIBIAL STYLUS spring was broken.Was there any reported patient or user harm? No.Was there a significant delay? No.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50853049 ↗
• MalfunctionMay 13, 2026Mechanical Jam

  THE SIGMA PARTIAL INSTRUMENT SET WAS OPENED BY THE THEATRE STAFF BY MISTAKE FOR THE 1ST CASE. THE SALES REPRESENTATIVE THEN PROCEEDED TO USE THE INSTRUMENTS FOR A DEMONSTRATION BEFORE OPENING THE 2ND SET FOR THE 3RD PATIENT ON THE LIST. THE TIBIAL STYLUS WAS JAMMED INTO A FIXED POSITION AND IT WAS IMPOSSIBLE TO ROTATE FROM SLOTTED TO NON-SLOTTED, AND USE EITHER THE 4MM OF 7MM RESECTION ENDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25161740 ↗
• MalfunctionJan 26, 2026Break

  IT WAS REPORTED THAT DURING INTRAOPERATIVE MEASUREMENT THE SMALL SPRING OF THE HPUNI TIB STYLUS WAS FOUND BROKEN INTO TWO PIECES. ALL FRAGMENTS WERE RETRIEVED, AND THERE WERE NO PATIENT ADVERSE CONSEQUENCES. THE SURGEON REQUIRED APPROXIMATELY TWO ADDITIONAL MINUTES TO COMPLETE TIBIAL CUTTING MEASUREMENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24181734 ↗
• MalfunctionNov 11, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THE STYLUS IS FIXED IN ONE POSITION AND WILL NOT ROTATE IN ANY DIRECTION. THE STYLUS 4MM-7MM IS FIXED AND A PARTICULAR DIRECTION AND CANNOT BE ALTERED FROM TO SLOTTED TO NON-SLOTTED, THE PATIENT WASN¿T HARMED. DID THE EVENT HAPPEN DURING A PROCEDURE? YES. EVENT OUTCOME/HOW WAS IT MANAGED? ANOTHER TRAY WAS USED. WAS THERE ANY CONSEQUENCE TO THE PATIENT DUE TO THE EVENT? NO HARM TO THE PATIENT. WAS THE SURGERY PROLONGED DUE TO THE EVENT? IF YES, CONFIRM - HOW MANY MINUTES DELAY. 5 MINUTES EXTRA TO EACH CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23526822 ↗