Arthrex® AR-8935L-24Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867050952), received between Jun 21, 2021 and Jun 21, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.

• MalfunctionJun 21, 2021Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE, WHEN THE SURGEON WAS PUTTING IN AN AR-8935L-24 IN THE PATIENT, THE TOP THREAD OF THE SCREW BROKE OFF. THE TITANIUM THREAD WENT THROUGH THE SURGEONS GLOVES BUT DID NOT PUNCTURE HIS SKIN. THE SURGEON WAS ABLE TO REMOVE THE SCREW AND PUT IN A DIFFERENT ONE FOR FINAL FIXATION, AND NO PIECES WERE LEFT BEHIND IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12032447 ↗