NA 2011-24-500Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10603295081982), received between Jul 10, 2023 and Jul 10, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionJul 10, 2023Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED. AND STATED, THAT WHILE IN SURGERY. THE DEPTH GAUGE WAS PERFECTLY FINE AND WAS BEING USED AS NORMAL. BUT, THE NEXT DAY WHEN THE SETS WERE PUT TOGETHER, IT WAS DETERMINED, TO BE BROKEN. IT WAS UNCLEAR WHETHER, IT WAS BROKEN WHEN IT WAS BEING CLEANED OR WHEN IT WAS TRANSPORTED AFTER SURGERY. BUT, IT WAS GOOD ON THE DAY OF THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17290067 ↗