Arthrex® AR-8941PRSRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867212398), received between Aug 4, 2023 and Aug 4, 2023 — classified as 1 malfunction.

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

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 18, 2026.

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.

• MalfunctionAug 4, 2023Positioning Failure; Use of Device Problem; Positioning Failure; Use of Device Problem

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-8941PRS PLANTAR LAPIDUS PLATE, SHORT RIGHT, HAD AN ISSUE UPON FIRST USE OF THE DEVICE. DURING A PLANTAR LAPIDUS PROCEDURE, WHEN THE SURGEON WAS TRYING TO USE THE PLATE INSIDE THE PATIENT, THE LOCKING SCREWS WOULD NOT LOCK WITH HOLES IN THE PLATE. NOTHING BROKE INSIDE THE PATIENT, AND THE PLATE WAS REMOVED IN ONE PIECE. A NEW AR-8941PRS PLANTAR LAPIDUS PLATE, SHORT RIGHT, WITH AN UNKNOWN LOT NUMBER, WAS OPENED AND USED TO COMPLETE THE PROCEDURE SUCCESSFULLY WITH NO IMPACT TO THE PATIENT. NO PICTURES WERE TAKEN, X-RAYS WERE NOT SAVED, AND THE DEVICE WAS DISCARDED BY THE FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17464487 ↗