Arthrex® AR-8007-25Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867042513), received between Nov 2, 2016 and Nov 2, 2016 — classified as 1 injury.

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.

• InjuryNov 2, 2016Break

  IT WAS REPORTED THAT PLATE BROKE POST-OP. SURGERY PERFORMED WAS AN ARTHRODESIS NAVICULAR CUNEIFORM MEDIAL. BREAKAGE OF THE PLATE WAS OBSERVED APPROXIMATELY SEVEN MONTHS AFTER INITIAL SURGERY. PATIENT DID FOLLOW SURGEON'S INSTRUCTIONS POST-OP. PATIENT HAD PERSISTING SWELLING AND PAIN, BREAKAGE OF THE PLATE WAS OBSERVED DURING X-RAY CONTROL. REVISION WAS PERFORMED ON (B)(6) 2016 WITH A NON-ARTHREX DEVICE. OUTCOME OF REVISION SURGERY WAS GOOD, PATIENT IS DOING WELL. PATIENT IS FEMALE, (B)(6).

  Patient problems: Pain; Swelling

  MAUDE report 6073149 ↗