NA 1806-0232Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540377951), received between May 20, 2019 and May 20, 2019 — 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.

• MalfunctionMay 20, 2019Break

  AS REPORTED BY REP: "SCREWDRIVER WAS BEING USED TO BACK OUT A COMPRESSION SCREW AND BROKE INSIDE THE T2 KNEE ARTHRODESIS NAIL". THIS WAS A PRIMARY PROCEDURE. COMPRESSION SCREW ORIGINALLY IMPLANTED HAD MISSED THE NAIL AND WAS BEING BACKED OUT AT THE TIME OF EVENT. THE SCREWDRIVER TIP WAS LEFT IN THE PATIENT. CASE WAS COMPLETED SUCCESSFULLY WITH A SURGICAL DELAY OF APPROXIMATELY 6 MINUTES. NO ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8625596 ↗