Arthrex® AR-1981-06SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867025318), received between Jun 10, 2024 and Jun 10, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• 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 19499298 ↗