Arthrex® AR-8935L-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867050914), received between Sep 5, 2018 and Sep 5, 2018 — classified as 1 injury.

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

• InjurySep 5, 2018Break

  DURING REMOVAL OF SCREWS/HARDWARE POST LISFRANC HEALING - SCREWS WERE BROKEN. THE DEVICES INVOLVED WERE AS FOLLOWS: AR-8935L-26 QTY 1. AR-8935L-20 QTY2. AR-8935-18 QTY 1. ADDITIONAL INFORMATION OBTAINED 8/27/18: THE ORIGINAL LISFRANC PROCEDURE TOOK PLACE ON (B)(6) 2017. IT WAS DISCOVERED THAT THE SCREWS WERE BROKEN AND THE REVISION WAS SCHEDULED DUE TO PATIENT PAIN AND BROKEN HARDWARE. THE DATE OF THE REVISION PROCEDURE WAS (B)(6) 2018, DURING WHICH BROKEN SCREWS WERE EXPLANTED. BOTH ORIGINAL AND REVISION PROCEDURES WERE PERFORMED AT THE SAME FACILITY BY THE SAME SURGEON. IT IS UNKNOWN IF ALL ORIGINAL IMPLANTS WERE EXPLANTED DURING THE REVISION. RISK MANAGER COULD ONLY CONFIRM THAT THE REPORTED SCREWS WERE EXPLANTED.

  Patient problems: Pain

  MAUDE report 7846930 ↗