Arthrex® AR-4019D-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867291935), received between Oct 19, 2021 and Oct 19, 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.

• MalfunctionOct 19, 2021Break

  ON (B)(6) 2021 IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA EMAIL THAT AN AR-4019D-1 SCREW DRIVER TIP IS BROKEN. THIS OCCURRED DURING A CASE, WHEN THE 6X20 SCREW WOULD NOT FIT OVER IT. THE SURGEON COMPLETED THE CASE GOING UP TO A BIGGER SIZE SCREW. THERE WAS NO PATIENT EFFECT REPORTED. ADDITIONAL INFORMATION PROVIDED ON 10/01/2021: PROCEDURE BEING DONE WAS AN MPFL. NO ATTACHMENT WAS USED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12659958 ↗