Arthrex® AR-8935-54Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867050761), received between Sep 28, 2021 and Sep 28, 2021 — classified as 1 malfunction.

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.

• MalfunctionSep 28, 2021Break

  ON 09/10/2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-8935-54 DRILL GUIDE LOCKING 3.5 SCREW, HEAD BROKE OFF DURING INSERTION. ALL FRAGMENTS WERE REMOVED. THIS WAS DISCOVERED DURING USE IN AN ANKLE ARTHROSCOPY ON (B)(6) 2021. THE CASE WAS COMPLETED BY USING AN AR-8935-56 SCREW INTO THE SAME INSERTION SITE. ADDITIONAL INFORMATION 9/13/2021 ON 09/13/2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-8935-54 DRILL GUIDE LOCKING 3.5 SCREW HEAD, BROKE OFF DURING INSERTION. THE SURGEON CUT THE AR-8925T K-LESS TIGHTROPE, AND REMOVE THE BROKEN SCREW AND AR-9943C-04 PLATE. THIS WAS DISCOVERED DURING USE IN AN ANKLE ARTHROSCOPY ON (B)(6) 2021. THE CASE WAS COMPLETED BY USING A NEW AR-8925T K-LESS TIGHTROPE WITH DRIVER, INTO THE SAME INSERTION SITE USING THE SAME AR-99343C-04 PLATE.

  Patient problems: Insufficient Information

  MAUDE report 12540226 ↗