Arthrex® AR-1981-08SRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888867025332), received between Jul 24, 2023 and Sep 19, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 19, 2025Material Fragmentation; Material Frayed; Material Fragmentation; Material Frayed

  ON 3RD SEP 2025, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA AN EMAIL THAT FOR 1 UNIT OF AR-1981-08S, SINGLE USE OSTEOCHONDRAL AUTOGRAFT TRANSFER SYSTEM OATS® SET AUTOGRAFT DIAMETER 8 MM, THE SURGEON FOUND THAT THE EDGE OF THE BLADE WAS FRAYED (REFER TO ATTACHED IMAGES). THE FRAGMENTS BROKE OFF INSIDE PATIENT AND THE FRAGMENTS WERE RETRIEVED FROM THE PATIENT. THIS WAS DETECTED DURING AN ARTHROSCOPIC-ASSISTED LEFT ANKLE TALUS CARTILAGE TRANSPLANTATION SURGERY ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING ANOTHER NEW AR-1981-08S. THERE WERE NO PATIENT HARM AND NO SECONDARY SURGERY NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23095079 ↗
• MalfunctionJul 2, 2025Material Twisted/Bent; Material Twisted/Bent

  ON 06/06/2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-1981-08S OATS HARVESTER TIP OF THE RECIPIENT HARVESTER CURLED UP. THIS CASE WAS COMPLETED BY USING ANOTHER PRODUCT OF SAME PRODUCT NUMBER. NO PATIENT HARMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22384028 ↗
• MalfunctionJun 10, 2024Break; Break

  ON 4/17/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT THE DONOR T-HANDLE FROM AN AR-1981-06S SINGLE USE OSTEOCHONDRAL AUTOGRAFT TRANSFER SYSTEM OATS SET AUTOGRAFT DIAMETER 6 MM METAL BEGAN TO WARP AFTER IT WAS INSERTED, AND AT THE DESIRED DEPTH. THE SURGEON WAS ABLE TO REMOVE THE DONOR T-HANDLE WITHOUT BREAKING IT. AN AR-8981-06S SMALL JOINT OATS, DONOR T-HANDLE WAS OPENED AND USED. THE SAME THING HAPPENED; IT WARPED, BUT DURING REMOVAL, IT BROKE IN THE CONDYLE. THEN, THE SURGEON ATTEMPTED TO USE AN AR-1981-08S, OATS SIZE 8MM, AND AN AR-1981-10S OATS, SIZE 10 MM, BUT IT WOULD NOT HARVEST A PLUG. AFTER AN EXTENDED PERIOD OF TIME, THE SURGEON WAS ABLE TO REMOVE THE BROKEN METAL WITH A CLAMP. THE SURGEON WAS ABLE TO USE THE PLUG OUT OF THE BROKEN PIECE AND COMPLETED THE CASE SUCCESSFULLY. THIS WAS DISCOVERED DURING AN AUTOGRAFT OATS TRANSFER PROCEDURE. ADDITIONAL INFORMATION RECEIVED ON 4/18/2023: THE CASE WAS DELAYED ABOUT FORTY-FIVE MINUTES TO AN HOUR, AND ADDITIONAL ANESTHESIA WAS ADMINISTERED.

  Patient problems: Insufficient Information

  MAUDE report 19499055 ↗
• MalfunctionMay 24, 2024Break; Break

  ON 11/04/2021, IT WAS REPORTED BY AN DISTRIBUTOR VIA E-MAIL THAT AN AR-1981-08S OATS SET BROKE WHEN THE SURGEON WAS REMOVING THE OSTEOCHONDRAL LESION. THIS WAS DISCOVERED DURING USE IN A PROCEDURE ON (B)(6) 2021. THE CASE WAS COMPLETED BY USING A NEW AR-1981-08S.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19393458 ↗
• MalfunctionJul 24, 2023Break; Break

  ON (B)(6)2023, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA SEMS THAT AN AR-1981-08S OSTEOCHONDRAL AUTOGRAFT TRANSFER SYSTEMS TIP BROKE. THIS OCCURRED DURING A PROCEDURE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED, ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONAL INFORMATION WAS PROVIDED ON (B)(6)2023, IT WAS REPORTED THAT THIS EVENT OCCURRED DURING AN OATS PROCEDURE. ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT, AND THE CASE WAS COMPLETED USING ANOTHER AR-1981-08S.

  Patient problems: Insufficient Information

  MAUDE report 17379884 ↗