NA 1806-0222Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540353245), received between Dec 13, 2021 and Dec 13, 2021 — 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. 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.

• MalfunctionDec 13, 2021Break; Break

  IT WAS REPORTED THAT DURING A REVISION OF THE PATIENT'S LEFT PROXIMAL HUMERUS, THE SURGEON ATTEMPTED TO REMOVE THE PROXIMAL LOCKING SCREWS USING THE TEARDROP HANDLE AND SHORT SCREWDRIVER SHAFT DESPITE BEING TOLD THAT THAT WAS NOT THE CORRECT INSTRUMENT TO USE. THE CONNECTION SNAPPED INSIDE THE ADAPTER. ALL PARTS WERE REMOVED AND THE CORRECT INSTRUMENT WAS USED TO REMOVE THE SCREWS. SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12982649 ↗