SIGMA 2024-57-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295083375), received between Jul 1, 2019 and Oct 23, 2024 — 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. How this data works · Data updated Oct 13, 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.

• MalfunctionOct 23, 2024Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024. THE TIP OF THE METAL GOUGE CURVE WAS CHIPPED AND NO LONGER IN A USEABLE CONDITION. THERE WAS NO PATIENT CONSEQUENCE. THERE WAS NO SURGICAL DELAY. THE DEVICE WAS DISPOSED OF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20517161 ↗
• MalfunctionNov 22, 2019Break; Break

  IT WAS REPORTED THAT THE TIP OF INSTRUMENT WAS BROKEN OFF. NEED A REPLACEMENT. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9364786 ↗
• MalfunctionJul 1, 2019Break; Corroded; Pitted; Break; Corroded; Pitted

  IT WAS REPORTED THAT THE SURGEON WAS USING THE GAUGE ON THE ANTERIOR DISTAL FEMUR TO REMOVE BONE. ON THE FIRST IMPACT THE GAUGE WAS BROKE. ALL PIECES WERE RECOVERED. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8748854 ↗