Arthrex® AR-6527SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867039902), received between Jul 5, 2022 and Jul 24, 2023 — classified as 2 injuries.

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. How this data works · Data updated Oct 13, 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.

• InjuryJul 24, 2023Break; Break

  ON 6/29/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT THE BANANA BLADE FROM AN AR-6527S HIP ARTHROSCOPE DISPOSABLE KIT BROKE INSIDE THE PATIENT. THIS WAS NOT DISCOVERED UNTIL THE PATIENT WENT FOR A POST-OPERATIVE VISIT. AN X-RAY SCAN CONFIRMED THERE WAS A FOREIGN OBJECT INSIDE THE PATIENT. ON (B)(6) 2023, THE PATIENT UNDERWENT REVISION SURGERY TO REMOVE THE BROKEN FRAGMENTS. THE REVISION PROCEDURE WAS CONDUCTED SMOOTHLY WITH NO COMPLICATIONS, AND THE FRAGMENTS WERE FULLY RETRIEVED. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 17378699 ↗
• InjuryJul 5, 2022Component Missing; Failure to Cut

  ON (B)(6) 2022 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-6527S BANANA BLADE HAD NO EDGE. DURING A CAPSULOTOMY THE DOCTOR MADE SEVERAL ATTEMPTS BUT IT WOULD NOT CUT. TO COMPLETE THE CASE THE SURGEON USED A SCALPEL. NO PATIENT AFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14914498 ↗