Arthrex® AR-6530Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867040113), received between Jun 1, 2021 and Jul 11, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 11, 2022Contamination; Packaging Problem

  IT WAS REPORTED THAT THE PACKAGING WAS COVERED WITH BLOODSTAINS. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THIS WAS NOTICED DURING INSPECTION. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14976789 ↗
• MalfunctionJun 1, 2021Break

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY SURGERY THE DEVICE BROKE AT THE EDGE INSIDE THE PATIENT. THE BROKEN OFF PIECE WAS RETRIEVED FROM THE PATIENT. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. 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: Insufficient Information

  MAUDE report 11912004 ↗