Arthrex® AR-8943BR-04Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867052550), received between Feb 13, 2018 and Feb 13, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 16, 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.

• InjuryFeb 13, 2018Insufficient Device Problem Information

  IT WAS REPORTED BY A FACILITY, WHO SENT A COPY OF A MEDWATCH (B)(4) WHICH THEY HAD FILED, THAT A PATIENT HAD ORIGINAL PLACEMENT OF HARDWARE THAT INCLUDED A PLATE AND SCREWS ON (B)(6) 2017 FOR A RIGHT DISPLACED LATERAL MALLEOLAR FRACTURE BY A HOSPITAL ORTHOPEDIC SURGEON. NO COMPLICATIONS WERE REPORTED. ON (B)(6) 2017 THE PATIENT WAS SEEN IN THE SURGEON'S OFFICE AND HAD COMPLAINTS OF INCREASING PAIN FOR THE PAST TWO MONTHS. THE PATIENT REPORTED TENDERNESS OVER PROMINENCE OF ONE OF THE SCREWS AS WELL AS THE ADDITIONAL AREA OF THE PLATE. THE SURGEON REVIEWED THE X-RAYS AND INDICATED NO CHANGE IN THE HARDWARE POSITION WITH NONE OF THE SCREWS BACKING OUT. ON (B)(6) 2017 THE PATIENT PRESENTED TO THE HOSPITAL WHERE THE ORTHOPEDIC SURGEON REPORTED THE FRACTURE AS HEALED BUT THE PATIENT REPORTED PAIN AND DYSFUNCTION WITH THE HARDWARE AND HAD WISHES FOR IT TO BE REMOVED. THE PATIENT HAD PLATE (AR-8943BR-04 LOCKING DISTAL FIBULA PLATE - (B)(4)) AND SCREW REMOVAL FROM HER RIGHT ANKLE UNDER GENERAL PLUS LOCAL ANESTHESIA. NO COMPLICATIONS WERE REPORTED FOLLOW-UP INVESTIGATION: PER FACILITY MEDWATCH REPORTER, THE SURGEON'S OFFICE NOTES INDICATED THAT THERE WAS PAIN AND "PROMINENCE AT LOCKING SCREW

  Patient problems: Pain

  MAUDE report 7266950 ↗