Arthrex® AR-1223SRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888867005532), received between Apr 25, 2022 and Nov 3, 2025 — classified as 1 injury, 3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 3, 2025Failure to Cut; Failure to Cut

  ON 10/22/2025, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA (B)(4) THAT AN AR-1223S 9MM CANNULATED CORING REAMER TREPHINE LOST ITS CUTTING ABILITY AND BECAME STRIPPED. IT WAS NECESSARY TO OPEN ANOTHER TREPHINE TO COMPLETE THE ACL RECONSTRUCTION. NO PATIENT WAS AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23452756 ↗
• MalfunctionOct 15, 2025Positioning Failure; Positioning Failure

  ON (B)(6) 2025, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA (B)(4) THAT AN AR-1223S 9MM CANNULATED CORING REAMER TREPHINE OPENED TOO WIDE AND LOST ITS INTENDED FUNCTION. THIS OCCURRED DURING AN ACL RECONSTRUCTION, AND NO PATIENT WAS AFFECTED. THE PROCEDURE WAS COMPLETED BY OPENING A SECOND TREPHINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23300174 ↗
• InjuryMay 10, 2023Break; Material Twisted/Bent; Break; Material Twisted/Bent

  ON 04/17/2023, IT WAS REPORTED BY A ARTHREX EMPLOYEE VIA SEMS THAT AN AR-1223S CORING REAMER BECAME DEFORMED AND BROKE. THIS WAS DISCOVERED DURING A CASE AND BROKE DURING USE. PER FACILITY: "THE PRODUCT WAS USED FOR ARTHROSCOPIC BONE GRAFT HARVESTING FROM THE TALUS ON (B)(6) 2023. DURING USE, THE TIP OF THE REAMER TOUCHED THE SHEATH OF THE CAMERA SCOPE, CAUSING DEFORMATION AND BROKEN WITHIN THE JOINT. AT THIS TIME, IT WAS ALSO CONFIRMED THAT METAL POWDER WAS GENERATED. THE DOCTOR IN CHARGE WAS ABLE TO EXTRACT A BONE GRAFT USING THE PRODUCT AS IT WAS, BUT THE BONE HOLE WAS ENLARGED DUE TO THE DEFORMATION OF THE PRODUCT. NO FURTHER INFORMATION IS AVAILABLE."

  Patient problems: Insufficient Information

  MAUDE report 16906579 ↗
• MalfunctionApr 25, 2022Break

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-1223S CORING REAMER WAS DAMAGED, NO ADDITIONAL INFORMATION WAS PROVIDED. 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 AN ACL RECONSTRUCTION PROCEDURE ON (B)(6) 2022. WHEN DRILLING THE TIBIA, THE REAMER BROKE INSIDE THE TIBIA. ALL FRAGMENTS WERE RETRIEVED AND THE CASE WAS COMPLETED SUCCESSFULLY WITH NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14194562 ↗