Arthrex® AR-8655-14Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867044364), received between Oct 14, 2016 and Feb 2, 2024 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 2, 2024Break; Break

  ON 01/18/2024, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-8655-14 RING CURETTE BROKE. THIS OCCURRED DURING AN ANKLE ARTHROSCOPY PROCEDURE, WHERE ALL FRAGMENTS WERE RETRIEVED. NO ADDITIONAL INFORMATION WAS PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN ASKED.

  Patient problems: Insufficient Information

  MAUDE report 18635912 ↗
• MalfunctionFeb 2, 2024Break; Break

  ON 01/18/2024, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT DURING A PROCEDURE ON (B)(6) 2024, A RING CURETTE, AR-8655-14, FROM THE ANKLE ARTHROSCOPY BOX BROKE DURING SURGERY WITH NO IMPACT ON THE PATIENT; NOT A SINGLE PART OF THE INSTRUMENT WAS LEFT IN THE PATIENT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18635575 ↗
• InjuryOct 14, 2016Material Fragmentation

  IT WAS REPORTED THAT AN AR-8655-14, STRAIGHT RING CURETTE FOR ANKLE ARTHROSCOPY, WAS BEING USED FOR AN ANKLE ARTHROSCOPY AND SYNDESMOSIS TIGHT ROPE PROCEDURE. THE TIP OF THE CURETTE WAS BROKEN-OFF DURING THE CURETTAGE STAGE OF THE ANKLE ARTHROSCOPY OF THE TALUS. SURGEON TRIED TO RETRIEVE THE METAL DEVICE TIP BY MAKING AN EXTRA INCISION AND TRIED UNDER FLUOROSCOPY TO GET ACCESS TO THE BROKEN PIECE BUT WAS UNABLE TO RETRIEVE IT. DEVICE TIP WAS LEFT UN-RETRIEVED. REMAINING PORTION WAS DISCARDED BY USER FACILITY. SKIN WAS CLOSED AND THE PATIENT WAS BROUGHT OUT OF THE OPERATING ROOM. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6030001 ↗