Arthrex® AR-400RAOPRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867223530), received between Sep 6, 2024 and Sep 10, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2024Break; Break

  IT WAS REPORTED THAT DURING AN HIP ARTHROPLASTY THE DEVICE BROKE. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE PART NUMBER AR-600. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20182394 ↗
• MalfunctionSep 6, 2024Break; Break

  IT WAS REPORTED THAT DURING A HIP ARTHROPLASTY SURGERY THE NEW DEVICE AR-400RAOP BROKE DURING THE SURGERY WHEN THE SURGEON WORKED ON THE HIP. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE (AR-600RAOP). IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. UPDATE AVOE 02-SEP-2024 IT WAS CONFIRMED THAT THE SURGEON TOOK THE MOTOR WITH THE AR-400RAOP TIP TO PREPARE THE ACETABULUM AND DURING PREPARATION THE TIP BROKE!

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20157377 ↗