Arthrex® AR-8943T-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867052789), received between Jun 2, 2020 and Jun 2, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (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.

• InjuryJun 2, 2020Break

  IT WAS REPORTED THAT A PATIENT HAD A PRIMARY ORIF ANKLE FX PERFORMED ON (B)(6) 2019, AND WAS WALKING AT 10 WEEKS. WITHOUT EXPERIENCING A NEW INJURY, THE IMPLANTED ARTHREX PLATE BROKE AND DISPLACED THE FX. THE PATIENT WILL NEED A SECOND SURGERY. THERE WAS NOT AN ARTHREX SALES REPRESENTATIVE PRESENT DURING THE INITIAL CASE. 10 WEEK X-RAYS REVEALING THE BROKEN PLATE HAVE BEEN PROVIDED TO ARTHREX. ADDITIONAL INFORMATION RECEIVED ON 03/20/2020: THE REP PROVIDED THE ORIGINAL SALES ORDER FROM THE PRIMARY PROCEDURE. THE FOLLOWING ARTHREX DEVICES WERE IMPLANTED DURING THE PRIMARY SURGERY; AR-8943T-10 // LOT: 474735 X 1, AR-8835-14 // LOT: 10266334 X 1, AR-8835-14 // LOT: 10268858 X 1, AR-8835-14 // LOT: 10273289 X 1, AR-8835-14 // LOT: 10291574 X 1, AR-8835-16 // LOT: 10221152 X 1, AR-8835-18 // LOT: 10211116 X 1, AR-8835-18 // LOT: 10223067 X 1, AR-8840-14 // LOT: 10035722 X 1. AT TIME OF INITIAL REPORT TO ARTHREX (MARCH 9-2020) OR WHEN THE ADDITIONAL INFORMATION WAS PROVIDED, ON MARCH 20-2020, THE SALES REP DID NOT HAVE ANY ADDITIONAL DETAILS PERTAINING TO THE EXPECTED SECOND SURGERY. ADDITIONAL INFORMATION OBTAINED 5/13/2020: THERE WAS A DELAY IN OBTAINING INFORMATION DUE TO THE COVID-19

  Patient problems: No Code Available

  MAUDE report 10108394 ↗