Arthrex® AR-4156DSRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867032859), received between Aug 31, 2021 and Jul 11, 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.

• MalfunctionJul 11, 2022Break

  ON 6/23/2022, IT WAS REPORTED BY A DISTRIBUTOR VIA SEMS THAT AN AR-4156DS TRIM-IT SPIN PIN METAL PORTION, SNAPPED OFF DURING INSERTION. ALL BROKEN PIECES WERE RETRIEVED AND CASE WAS COMPLETED WITHOUT FURTHER ISSUES. THIS WAS DISCOVERED DURING A TOE REALIGNMENT PROCEDURE ON (B)(6) 2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14976761 ↗
• MalfunctionAug 31, 2021Break

  THE SURGEON AGREED TO TRIAL THE TRIM-IT SPIN PINS FOR PIP FUSIONS. DURING THE CASE, AFTER HE TRIMMED THE PIN AND INSERTED IT IN THE TOE, HE HELD IT WITH AN ARTERY CLIP AND ACTIVATED THE DRILL TO BREAK THE PIN. HOWEVER, INSTEAD OF THE PIN BREAKING AT THE BREAK-OFF POINT, THE PIN BROKE AT THE POINT WHERE THE ARTERY CLIP WAS HOLDING IT. THIS HAPPENED MULTIPLE TIMES DURING THE CASE.

  Patient problems: Insufficient Information

  MAUDE report 12393470 ↗