Arthrex® AR-8944PR-20Recalls & reported problems
Arthrex, Inc. · PHALANGEAL REAMER, 20MM · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888867053229), received between Aug 30, 2023 and Sep 5, 2023 — classified as 4 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
Device problems
- Dull, Blunt4
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 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 17683666 ↗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 17662248 ↗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 17662080 ↗MalfunctionAug 30, 2023Dull, Blunt; Dull, Blunt
ON (B)(6) 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 17653556 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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