Arthrex® AR-6527-19Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867039896), received between Apr 4, 2025 and Apr 4, 2025 — classified as 1 malfunction.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 4, 2025Break; Break

  ON 03/17/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT (4) AR-3636H SELF BUNCHING 1.8 KNOTLESS HIP FIBERTAKS FAILED, AN AR-3600ND-4HF DISPOSABLE FLEXIBLE FLUTED DRILL BROKE, AND AN AR-6527-19 HOOK KNIFE BROKE. THIS OCCURRED DURING A HIP ARTHROSCOPY ON (B)(6) 2025 THE FIRST ANCHOR DID NOT HOLD IN THE BONE AND THE INSERTER WAS BENT. THE SECOND ONE BACKED OUT OF THE BONE, THE THIRD ONES SUTURE WAS FRAYED AND WAS NOT USED. THE FOURTH ONE WAS PLACED IN THE BONE AND THEN WHEN CONVERTING THE SUTURE, THE TENSIONING BROKE. THE IMPLANT REMAINED IN THE PATIENT. THEY SWITCHED TO AN AR-3600ND-4HF DRILL WHICH BROKE. ALL FRAGMENTS WERE RETRIEVED. THEY PROCEEDED WITH STANDARD PUSHLOCKS. THE AR-6527-19 15244183 BENT AND BROKE. ALL FRAGMENTS WERE RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21773528 ↗