NA 2001-84-110Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10603295080442), received between Sep 17, 2021 and Sep 17, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Failure to Cut” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2021Failure to Cut; Failure to Cut

  COMPASS CASE (B)(4) REPORTS: IT WAS REPORTED THAT THE SURGEON COMPLAINED THAT THE 11 MM AND THE 14 MM REAMERS WERE DULL. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12487816 ↗