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

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867050921), received between Jan 9, 2024 and Feb 15, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Fitting Problem” (3 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 15, 2024Break; Fitting Problem; Break; Fitting Problem

  IT WAS REPORTED THAT DURING A LAPIDUS SURGERY THE SCREW DID NOT FIT PROPERLY INTO THE PLATE. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. UPDATE 02-FEB-2024 DW: FURTHER INFORMATION WAS PROVIDED THAT WHILE THE SURGEON INSERTED THE SECOND SCREW IT BROKE OFF. THE BROKEN PIECE WAS RETRIEVED AND THE SURGERY WAS FINISHED SUCCESSFULLY WITH AN ADDITIONAL SCREW WITH THE SAME PART NUMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18710615 ↗
• MalfunctionFeb 15, 2024Positioning Failure; Fitting Problem; Positioning Failure; Fitting Problem

  IT WAS REPORTED THAT DURING A LAPIDUS SURGERY THE SCREW DID NOT FIT PROPERLY INTO THE PLATE. THE SCREW WAS INSERTED EITHER WAY. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. UPDATE 02-FEB-2024 DW: FURTHER INFORMATION WERE PROVIDED THAT WHILE THE SURGEON INSERTED THE SECOND SCREW IT BROKE OFF. THE BROKEN PIECE WAS RETRIEVED AND THE SURGERY WAS FINISHED SUCCESSFULLY WITH AN ADDITIONAL SCREW WITH THE SAME PART NUMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18710570 ↗
• MalfunctionJan 9, 2024Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT DURING A LAPIDUS SURGERY THE SCREW COULD NOT BE INSERTED BECAUSE THE THREAD DID NOT FIT. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18475010 ↗