Arthrex® AR-1224SRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00888867005648), received between May 23, 2019 and Mar 1, 2024 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (3 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.

• MalfunctionMar 1, 2024Material Deformation; Material Deformation

  ON (B)(6) 2024, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA SEMS (B)(4) THAT THE SURGEON HAS USED THE CORING REAMER, AR-1224S, IN MANY CASES AND IS FAMILIAR WITH THE TECHNIQUE. HE FOLLOWED THE PROCEDURE TO DRILL THE TIBIAL TUNNEL AND UPON EXITING INTO JOINT, THE TIP OF THE CORING REAMER EXPANDED AND FLOWERED OPEN. THERE ARE MULTIPLE SPLITS IN THE REAMER NEAR THE TIP. HE WAS ABLE TO REMOVE THE DRILL AND NO REMAINS WERE INSIDE THE JOINT. THE ISSUE WAS NOTICED AFTER THE DEVICE EXITED THE CAVITY. THERE WAS NO ADVERSE EFFECT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18816265 ↗
• MalfunctionNov 22, 2023Material Deformation; Material Deformation

  ON 10/27/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT (QTY. 2) OF AN AR-1224S CANNULATED CORING REAMER WITH COLLARED PIN, 10 MM, HAD AN ISSUE. WHEN REAMING THE DEVICE, THE TIP FANNED OUT INTO A FLOWER-LIKE FORM INSTEAD OF THE EXPECTED CIRCULAR FINISH. THIS WAS DISCOVERED DURING AN UNSPECIFIED PROCEDURE, WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18192043 ↗
• MalfunctionNov 20, 2023Material Deformation; Material Deformation

  ON (B)(6). 2023 IT WAS REPORTED, BY A SALES REPRESENTATIVE VIA (B)(4). THAT (QTY. 2) OF AN AR-1224S CANNULATED CORING REAMER WITH COLLARED PIN, 10 MM, HAD AN ISSUE. WHEN REAMING THE DEVICE, THE TIP FANNED OUT INTO A FLOWER-LIKE FORM INSTEAD OF THE EXPECTED CIRCULAR FINISH. THIS WAS DISCOVERED DURING AN UNSPECIFIED PROCEDURE, WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18174217 ↗
• InjuryMay 24, 2021Material Twisted/Bent

  IT WAS REPORTED THAT THE METAL AT THE LEADING EDGE OF THE REAMER MUSHROOMED WHEN IT WAS DRILLED INTO THE BONE DURING AN ACL CASE. IT WENT FROM 10 MM TO 24 MM. IT STOPPED BEFORE IT HIT THE JOINT; THERE WAS A HAIRLINE FRACTURE IN THE TIBIA. THE PATIENT WAS MALE, (B)(6) YEARS.

  Patient problems: Bone Fracture(s)

  MAUDE report 11871773 ↗
• InjurySep 2, 2020Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED DURING AN ACL RECONSTRUCTION THE TIP OF THE REAMER EXPANDED AND PRODUCED SHARDS OF METAL. A SHAVER WAS USED TO DISTRACT AS MUCH OF THE METAL DEBRIS AS POSSIBLE. THE DOCTOR DID NOT DO AN X-RAY TO INSURE ALL METAL WAS RECOVERED AND THE REP IS NOT 100% CONFIDENT ALL WAS RETRIEVED. THE REST OF THE CASE WAS COMPLETED WITHOUT ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10483716 ↗
• InjuryMay 23, 2019Break; Smoking

  IT WAS REPORTED THAT DURING AN ACL PROCEDURE, WHILE REAMING WITH THE 10MM CORING REAMER, AR-1224S, THE CORING REAMER BEGAN TO SMOKE AND THEN FELL APART. THIS CAUSED A FRACTURE IN THE FEMORAL CONDOYLE. NO FURTHER DETAILS. ADDITIONAL INFORMATION REQUESTED. ADDITIONAL INFORMATION OBTAINED 4/26/2019: FACILITY PROVIDED COPY OF HANDWRITTEN MEDWATCH REPORT (NO REPORT NUMBER LISTED). FACILITY MEDWATCH REPORT STATED THE FOLLOWING: A CORE REAMER SHATTERED RESULTING IN LIFTING A CENTRAL CORE OF THE TIBIAL PLATEAU, CAUSING AN INTRA-ARTICULAR TIBIAL PLATEAU FRACTURE OF THE CENTRAL ASPECT OF THE PLATEAU. THIS REQUIRED SURGICAL REPAIR. ADDITIONAL INFORMATION PROVIDED 5/29/2019: THE SURGEON USED THE CORING REAMER TO BREAK THROUGH THE CORTEX INSTEAD OF AN OVER-SIZED REAMER.

  Patient problems: Bone Fracture(s)

  MAUDE report 8636742 ↗