Arthrex® AR-8935L-18SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867050907), received between Sep 18, 2024 and Feb 2, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (2 reports).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 2, 2026Positioning Failure

  IT WAS REPORTED THAT DURING THE LAPIDUS PROCEDURE, THE SCREW SPUN AROUND IN THE PRE-DRILLED HOLE IN THE PLATE AND SLIPPED OUT. AS A RESULT, THE SCREWS AND THE PLATES COULD NOT BE USED FOR FIXATION. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24233073 ↗
• MalfunctionFeb 2, 2026Positioning Failure

  IT WAS REPORTED THAT DURING THE LAPIDUS PROCEDURE, THE SCREW SPUN AROUND IN THE PRE-DRILLED HOLE IN THE PLATE AND SLIPPED OUT. AS A RESULT, THE SCREWS AND THE PLATES COULD NOT BE USED FOR FIXATION. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24232672 ↗
• MalfunctionSep 18, 2024Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY THE LOCKING SCREW COULD NOT BE TIGHTENED IN THE PLATE. THE THREAD TWISTED AND THE SCREW WAS NOT USABLE. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20248994 ↗