Arthrex® AR-8655-04Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00888867044272), received between Oct 4, 2021 and Aug 27, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 27, 2025Break; Break

  ON (B)(6) 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-07016524 THAT AN AR-8655-04 RING CURRETTE RING BROKE OFF THE CURRETTE. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22903850 ↗
• MalfunctionJan 24, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ANKLE FUSION SURGERY THE TIP OF THE CURETTE BROKE OFF IN THE JOINT. ALL BROKEN PARTS WERE RETRIEVED FROM THE PATIENT. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE (AR-8655-02). IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18573718 ↗
• MalfunctionAug 3, 2023Break; Break

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-8655-04 RING CURRETTE BROKE. THIS OCCURRED WHILE BEING USED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED, ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17454283 ↗
• MalfunctionFeb 20, 2023Break; Entrapment of Device

  ON 1/30/2023 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-8655-04 RING CURRETTE BROKE OFF INSIDE THE PATIENT DURING THE ANKLE ARTHROSCOPY/MICRO FRACTURE REPAIR. THE TIP OF CURETTE BROKE OFF INSIDE THE JOINT WHEN TRYING TO REMOVE LOOSE CARTILAGE DURING THE MIDDLE OF THE ARTHROSCOPY PROCEDURE. THE SURGEON HAD TO OPEN LATERALLY SINCE HE WAS NOT ABLE TO RETRIEVE THE PIECE INSIDE THE JOINT. THEY USED FLURO TO LOCATED THE BROKEN PIECE BUT STILL THE SURGEON NEVER RETRIEVED THE BROKEN PIECE.

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient

  MAUDE report 16403787 ↗
• MalfunctionJun 20, 2022Break

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-8655-04 RING CURRETTE HAD AN ISSUE, THE TIP BROKE OFF. THIS WAS DISCOVERED DURING USE WITH NO IMPACT TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ON (B)(6) 2022, THE SALES REPRESENTATIVE STATED THE FOLLOWING INFORMATION VIA PHONE: THIS EVENT OCCURRED DURING A KNEE ARTHROSCOPY PROCEDURE ON (B)(6) 2022. THE DEVICE BROKE INSIDE THE PATIENT, ALL FRAGMENTS WERE REMOVED AND THE CASE WAS COMPLETED SUCCESSFULLY WITH NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14744072 ↗
• MalfunctionOct 4, 2021Break

  IT WAS REPORTED THAT DURING ANKLE ARTHROSCOPY PROCEDURE THE CURETTE BROKE. THE BROKEN OFF PIECE HAS BEEN RETRIEVED FROM THE PATIENT. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. 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. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12570533 ↗