Arthrex® AR-8973-11Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867302471), received between May 1, 2024 and Jun 14, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fitting Problem” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 14, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED BY THE SALES REP THAT THE AR-8973-11, SCREW DRIVER SHAFT REQUIRES EXCESSIVE FORCE TO RELEASE SCREW. SCREW DRIVER SHAFT CAPTURED SCREW SO TIGHTLY THAT IT DOES NOT EASILY DISENGAGE. THIS ISSUE CAUSED THE SCREW TO PULL OUT OF BONE OF THE PATIENT. ADDITIONAL INFORMATION REQUESTED. ADDITIONAL INFORMATION PROVIDED 3/3/21: PROCEDURE BEING PERFORMED WAS A ANKLE FRACTURE WITH FIBULOCK. ANOTHER ANKLE FRACTURE TRAY WAS OPENED TO USE A T10 SCREWDRIVER TO COMPLETE THE CASE. THE BONE OF THE PATIENT WAS NOT HARMED WHEN THE SCREW PULLED OUT, BUT THE SURGEON DID LOSE A POINT OF FIXATION THROUGH THE FIBULOCK NAIL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19542912 ↗
• MalfunctionMay 1, 2024Fitting Problem; Fitting Problem

  ON 12/16/2021 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-8973-11 FIBULOCK DRIVER IS NOT PICKING UP SCREWS AS EXPECTED. THIS WAS DISCOVERED DURING A PROCEDURE. CASE WAS COMPLETED SUCCESSFULLY AND PATIENT WAS NOT AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19220687 ↗