SIGMA 2024-52-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295083283), received between Oct 19, 2021 and Oct 26, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Naturally Worn” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 26, 2021Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THIS INSTRUMENT WAS WORN AND DIDN¿T DRILL WELL. ALTERNATIVE USED TO COMPLETE SURGERY. NO PATIENT IMPACT OR DELAY TO SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12697096 ↗
• MalfunctionOct 19, 2021Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE DRILL WAS WORN AND DIDN¿T DRILL WELL. NO PATIENT IMPACT OR DELAY TO SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12658462 ↗