Arthrex® AR-8610D-43Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867197282), received between Sep 12, 2022 and Sep 12, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

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.

• MalfunctionSep 12, 2022Break

  WHILST TIGHTENING HCS SCREW, CANNULATED T15 SCREWDRIVER SHAFT BROKE UPON TIGHTENING. A SECOND T15 CANNULATED SCREWDRIVER WAS USED WHICH ALSO BROKE. ALL PIECES WERE RETRIEVED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information

  MAUDE report 15401857 ↗
• MalfunctionSep 12, 2022Break

  WHILST TIGHTENING HCS SCREW, CANNULATED T15 SCREWDRIVER SHAFT BROKE UPON TIGHTENING. A SECOND T15 CANNULATED SCREWDRIVER WAS USED WHICH ALSO BROKE. ALL PIECES WERE RETRIEVED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information

  MAUDE report 15401802 ↗