Arthrex® AR-21020Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00888867026056), received between Apr 11, 2018 and Jul 8, 2025 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Break” (5 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. How this data works · Data updated Oct 13, 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.

• MalfunctionJul 8, 2025Break; Break

  IT WAS REPORTED THAT DURING A SURGERY THE DEVICE BROKE. ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH AN EQUIVALENT DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22440510 ↗
• MalfunctionMay 15, 2025Break; Break

  IT WAS REPORTED THAT DURING A SURGERY THE DEVICE BROKE OFF. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT CURETTE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22026452 ↗
• MalfunctionOct 26, 2023Crack; Crack

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-21020 CURETTE RING IS CRACKED. THE ISSUE OCCURRED DURING THE CASE AND WAS TAKEN OUT OF SERVICE IMMEDIATELY. THE PATIENT WAS NOT AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18013429 ↗
• MalfunctionAug 3, 2023Break; Break

  ON 7/5/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-21020 CURETTE HAD AN ISSUE. DURING THE SURGERY, THE SURGEON WAS PREPARING THE GLENOID FOR A LABRAL REPAIR, AND WHILE USING THE CURETTE, IT BROKE WHEN IT MADE CONTACT WITH THE BONE AND SNAPPED IN HALF. THE BROKEN PIECE WAS RETRIEVED FROM THE JOINT, AND THE CASE WAS CONTINUED WITHOUT THE PATIENT BEING AFFECTED. THIS OCCURRED DURING USE IN A LABRAL REPAIR PROCEDURE WITH NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ON 7/18/2023, THE SALES REPRESENTATIVE STATED THE FOLLOWING INFORMATION VIA PHONE: THIS EVENT OCCURRED DURING A LABRAL REPAIR PROCEDURE ON (B)(6) 2023. AFTER THE BROKEN PIECE HAD BEEN RETRIEVED, A NEW AR-21020 CURETTE WITH AN UNKNOWN LOT NUMBER WAS USED TO COMPLETE THE CASE SUCCESSFULLY WITH NO PATIENT HARM. THERE WAS NO CASE DELAY OR ANY ADVERSE EFFECT TO THE PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17450172 ↗
• MalfunctionDec 27, 2022Break

  ON 12/06/2022 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-21020 RING CURETTE BROKE OFF IN THE PATIENT. ALL WAS RETRIEVED AND THE PATIENT WAS NOT AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16051439 ↗
• InjuryApr 11, 2018Break; Migration or Expulsion of Device

  IT WAS REPORTED THAT DURING AN ANKLE ARTHROSCOPIC ARTHRODESIS, THE ANKLE WAS DECORTICATED WITH A 4MM BURR, A 3.5MM FULL RADIUS RESECTOR AND RING CURETTES. DURING DECORTICATION WITH RING CURETTES, IT WAS NOTED THAT A SMALL FRAGMENT OF THE RING CURETTE BROKE AND ENDED UP IN THE POSTERIOR RECESS OF THE ANKLE. ATTEMPTS TO RETRIEVE IT WERE UNSUCCESSFUL; SURGEON OPTED TO LEAVE IT IN INSTEAD OF POSSIBLY CAUSING MORE HARM. PATIENT WILL BE MONITORED BY SURGEON. PATIENT IS A (B)(6) MALE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7422027 ↗