Arthrex® AR-8944MR-22Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888867053175), received between Feb 6, 2023 and Sep 5, 2023 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Dull, Blunt” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 5, 2023Dull, Blunt; Dull, Blunt

  ON 8/8/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THE FOLLOWING: AN AR-8944MR-18 METATARSAL REAMER (BATCH#041309) IS GETTING DULL. AN AR-8944MR-20 METATARSAL REAMER (BATCH#041329) IS GETTING DULL. AN AR-8944MR-22 METATARSAL REAMER (BATCH#041302) IS GETTING DULL. AN AR-8944PR-18 PHALANGEAL REAMER (BATCH#041308) IS GETTING DULL. AN AR-8944PR-20 PHALANGEAL REAMER (BATCH#041326) IS GETTING DULL. AN AR-8944PR-22 PHALANGEAL REAMER (BATCH #041309) IS GETTING DULL. THIS WAS DISCOVERED DURING AN UNSPECIFIED PROCEDURE, WITH NO ADVERSE EVENT OR PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17683592 ↗
• MalfunctionAug 31, 2023Dull, Blunt; Dull, Blunt

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THE FOLLOWING: AN AR-8944MR-18 METATARSAL REAMER (BATCH#032018) IS GETTING DULL. AN AR-8944MR-20 METATARSAL REAMER (BATCH#031543) IS GETTING DULL. AN AR-8944MR-22 METATARSAL REAMER (BATCH#041429) IS GETTING DULL. AN AR-8944PR-18 PHALANGEAL REAMER (BATCH#031841) IS GETTING DULL. AN AR-8944PR-20 PHALANGEAL REAMER (BATCH#032010) IS GETTING DULL. AN AR-8944PR-22 PHALANGEAL REAMER (BATCH #041415) IS GETTING DULL. THIS WAS DISCOVERED DURING AN UNSPECIFIED PROCEDURE, WITH NO ADVERSE EVENT OR PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17662238 ↗
• MalfunctionAug 31, 2023Dull, Blunt; Dull, Blunt

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THE FOLLOWING: AN AR-8944MR-18 METATARSAL REAMER IS GETTING DULL. AN AR-8944MR-20 METATARSAL REAMER IS GETTING DULL. AN AR-8944MR-22 METATARSAL REAMER IS GETTING DULL. AN AR-8944PR-18 PHALANGEAL REAMER IS GETTING DULL. AN AR-8944PR-20 PHALANGEAL REAMER IS GETTING DULL. AN AR-8944PR-22 PHALANGEAL REAMER IS GETTING DULL. THIS WAS DISCOVERED DURING AN UNSPECIFIED PROCEDURE, WITH NO ADVERSE EVENT OR PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17662078 ↗
• MalfunctionAug 30, 2023Dull, Blunt; Dull, Blunt

  ON 8/2/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-8944MR-20 METATARSAL REAMER AND AN AR-8944MR-22 METATARSAL REAMER, AND AN AR-8944PR-20 PHALANGEAL REAMER AND AN AR-8944PR-22 PHALANGEAL REAMER WERE ALL GETTING DULL. THIS WAS DISCOVERED DURING AN UNSPECIFIED PROCEDURE, WITH NO REPORTED ADVERSE EVENT OR PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17653549 ↗
• MalfunctionFeb 6, 2023Break; Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT A AR-8944MR-22 REAMER GRABBED ONTO THE BONE AND RIPPED IT APART SO INSTEAD OF SHAVING DOWN TO A CONE SHAPE IT JUST BROKE. THIS OCCURRED DURING A CASE, 45 ADDITIONAL MINUTES WERE ADDED TO TRY FIXING ALL THE BROKEN BONES. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Bone Fracture(s); Insufficient Information

  MAUDE report 16303173 ↗