Arthrex® AR-8610C-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867198340), received between Nov 15, 2021 and Nov 15, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Material Deformation” (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.

• InjuryNov 15, 2021Material Deformation; Material Twisted/Bent

  ON (B)(6) 2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-8950SD-10 DRIVER, BECAME TWISTED. THIS WAS DISCOVERED TAKING OUT A SCREW AND THE DRIVER TWISTED AND BECAME DEFORMED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED. ADDITIONAL INFORMATION 10/27/2021 ON 10/27/2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-8950SD-10 DRIVER, BECAME TWISTED WHEN REMOVING A 4.0 HEADLESS COMPRESSION SCREW FROM THE SUBTALAR JOINT. THE SURGEON USED A TREPHINE TO RELEASE SCREW FROM BONE THEN PULLED THE SCREW OUT WITH A HEMOSTAT. THE REVISION WAS BEING PERFORM FOR PAINFUL HARDWARE.

  Patient problems: Insufficient Information

  MAUDE report 12814656 ↗