SIGMA 2024-11-507Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295082873), received between Sep 27, 2018 and Jun 5, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 5, 2023Break; Break

  DEVICE REPORT FROM THE UNITED KINGDOM REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON AN UNKNOWN DATE, TWO TIBIAL TRIALS WERE BROKEN. THE HEAD ON ONE END HAD SNAPPED. PROCEDURE WAS COMPLETED WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A SIGMA HP UNI TIB TRL SZ3 7MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17060664 ↗
• MalfunctionDec 10, 2019Break; Break

  INSTRUMENT FROM AN ORTHKIT LOAN SET BROKE INTO 2 PARTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9443519 ↗
• MalfunctionSep 27, 2018Break; Break

  IT WAS REPORTED THAT THE SIGMA HP UNI TIB TRL SZ5 7MM BROKE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7917197 ↗