Arthrex® ABS-8981-12SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867343894), received between Sep 17, 2024 and Sep 17, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Dull, Blunt” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2024Dull, Blunt; Dull, Blunt

  ON 09/03/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT (QTY. 2) OF AN ABS-8981-12S OATS 2.0 SINGLE-USE SET WAS RECEIVED WITH A DULL TIP ON THE HANDLE AND NOT SHARP, AND THE INTERNAL PLUNGE WAS STUCK/TOO TIGHT. THEN, ANOTHER ABS-8981-12S OATS 2.0 SINGLE-USE SET FROM THE SAME LOT WAS OPENED, AND THE SAME ISSUE OCCURRED. THE CASE WAS COMPLETED SUCCESSFULLY USING FORCE AND A BIGGER MALLET TO MALLET THE DISPOSABLE TO DOWNSIZE THE ALLOGRAFT. WHEN FORCE WAS APPLIED THROUGH THE GRAFT, THEY WERE CONCERNED THAT THE GRAFT WOULD BREAK OR THE DEVICE WOULD GO THROUGH. THERE WAS NO IMPACT ON THE PATIENT. THIS WAS DISCOVERED DURING AN OAT PROCEDURE ON THE ELBOW PROCEDURE ON (B)(6) 2024, WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20238218 ↗
• MalfunctionSep 17, 2024Dull, Blunt; Dull, Blunt

  ON 09/03/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-(B)(4) THAT (QTY. 2) OF AN ABS-8981-12S OATS 2.0 SINGLE-USE SET WAS RECEIVED WITH A DULL TIP ON THE HANDLE AND NOT SHARP, AND THE INTERNAL PLUNGE WAS STUCK/TOO TIGHT. THEN, ANOTHER ABS-8981-12S OATS 2.0 SINGLE-USE SET FROM THE SAME LOT WAS OPENED, AND THE SAME ISSUE OCCURRED. THE CASE WAS COMPLETED SUCCESSFULLY USING FORCE AND A BIGGER MALLET TO MALLET THE DISPOSABLE TO DOWNSIZE THE ALLOGRAFT. WHEN FORCE WAS APPLIED THROUGH THE GRAFT, THEY WERE CONCERNED THAT THE GRAFT WOULD BREAK OR THE DEVICE WOULD GO THROUGH. THERE WAS NO IMPACT ON THE PATIENT. THIS WAS DISCOVERED DURING AN OAT PROCEDURE ON THE ELBOW PROCEDURE ON (B)(6) 2024, WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20238003 ↗