Arthrex® AR-8935L-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867051010), received between Oct 19, 2016 and Oct 19, 2016 — classified as 1 injury.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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.

• InjuryOct 19, 2016Device Dislodged or Dislocated

  IT WAS REPORTED VIA AN ARTHREX WEBSITE INQUIRY THAT A PATIENT WITH A SCREW AND PLATE IN HER ANKLE NEEDS TO HAVE IT REMOVED. SURGEON REPORTED TO SALES REP THAT A SCREW IS BACKING OUT. THE ORIGINAL SURGERY TOOK PLACE (B)(6) 2014 ON THE RIGHT FOOT BY A DIFFERENT SURGEON AT A DIFFERENT FACILITY. THE DEVICES ARE REPORTED TO BE AN ARTHREX 6.5 MM CANNULATED SCREWS AND 4.5 CANNULATED SCREWS WITH AN H-PLATE AND LOCKING SCREWS. ADDITIONAL INFORMATION OBTAINED ON 09/27/16: REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2016 TO REMOVE THE AR-8942R-M, H-PLATE ((B)(4) (B)(6)), AND THE SCREWS, AR-8935-24, LO-PRO SCREW, QTY 1 ((B)(4) (B)(6)), AR-8935L-26, LOCKING SCREW, QTY 1 ((B)(4) (B)(6)) AND AR-8935L-30, LOCKING SCREW, QTY 2 ((B)(4) (B)(6)).

  Patient problems: No Code Available

  MAUDE report 6039362 ↗