Arthrex® AR-8981-06SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867056817), received between May 11, 2023 and May 11, 2023 — classified as 1 injury.

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

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Nov 2, 2022Open, Classified

   The devices may be packaged with the wrong reamer size.

   Z-0465-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

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.

• InjuryMay 11, 2023Break; Break

  ON (B)(6) 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; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16914428 ↗