Arthrex® AR-8981-08SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867056824), received between May 23, 2024 and Nov 24, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (2 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 24, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 04 NOVEMBER 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-8981-08S, SMALL JOINT OATS SET 8 MM WAS REPORTED TO BE STUCK DURING USE. THIS OCCURRED ON (B)(6) 2025 DURING AN ACL STAGE 1 GRAFTING OF PREVIOUS ACL TUNNEL. IT WAS REPORTED THAT WHILE USING 8MM OATS KIT, THE SCREW TAP WOULD NOT EJECT THE BONE DOWEL. THE CASE WAS COMPLETED SUCCESSFULLY USING ANOTHER KIT AND THIS WORKED CORRECTLY. THERE WAS CASE INVOLVEMENT.

  Patient problems: Insufficient Information

  MAUDE report 23630489 ↗
• MalfunctionAug 19, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 07/31/2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-8981-08S SMALL JOINT OATS SET WHEN TRYING TO HARVEST THE DONOR SIDE WITH A HARVESTER, IT DIDN'T WORK, EVEN THOUGH FOLLOWING THE INSTRUCTIONS IN THE MANUAL. THERE IS NO SPECIFIC ISSUE REPORTED. THE COMPLAINT WAS THAT THE SAMPLE WAS NOT EXTRACTED PROPERLY EVEN THOUGH IT WAS USED ACCORDING TO THE INSTRUCTIONS. A NEW ONE WAS OPENED AND WAS ABLE TO HARVEST IT CLEANLY. THE PROCESS WAS COMPLETED WITHOUT ANY PROBLEMS AND NO PATIENT HARMS. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22842277 ↗
• MalfunctionMay 23, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  ON 06/14/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT A AR-8981-08S SMALL JOINT OATS KIT HAD THE WRONG SIZE REAMER IN THE KIT. IT WAS AN 8MM OATS KIT AND HAD A 6MM REAMER IN IT. THIS WAS DISCOVERED DURING AN UNKNOW TIME, WITH NO PATIENT EFFECT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19387375 ↗