Arthrex® AR-6400RBERecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867039124), received between Apr 18, 2018 and Apr 18, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Metal Shedding Debris” (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.

• InjuryApr 18, 2018Metal Shedding Debris; Split

  IT WAS REPORTED THAT DURING A HIP ARTHROSCOPY PROCEDURE, THE SURGEON NOTICED THAT THE 40 MM ROUND BURR WAS SPLITTING AND PRODUCING METAL SHAVINGS IN THE JOINT. A SECOND BURR OF THE SAME LOT WAS OPENED AND USED AND AGAIN, THE BURR SPLIT AND PRODUCED METAL SHAVINGS. THE SURGEON WAS ABLE TO REMOVE MOST OF THE SHAVINGS VIA SUCTION AND THE CASE WAS COMPLETED.

  Patient problems: Foreign Body In Patient

  MAUDE report 7439301 ↗