NA 03.420.050Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982335791), received between Jan 27, 2026 and Jan 27, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Deformation” (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.

• MalfunctionJan 27, 2026Material Deformation

  IT WAS REPORTED THAT DURING A PROCEDURE ON AN UNKNOWN DATE, THERE WERE BENT DEPTH GAUGES. DURING A CASE, A TROCAR WAS USED AS A REDUCTION TOOL AND WAS BENT IN THE PROCESS. OPERACE TREPHINES WERE USED FOR BROKEN SCREWS AND DID NOT WORK. NO SURGERY DELAYED DUE TO THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24189048 ↗