Arthrex® AR-8943BR-05Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867052567), received between Sep 5, 2018 and May 2, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Defective Device” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 2, 2024Defective Device; Defective Device

  ON 8/30/2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-8943BR-05 DISTAL LOCK FIBULA PLATE, WAS NOT THREADED PROPERLY. THE SURGEON WAS UNABLE TO INSERT THE 2.7 DISTAL LOCKING SCREW. THE PLATE AND SCREWS WERE REMOVED. THIS WAS DISCOVERED DURING USE IN AN ANKLE ARTHROSCOPY ON (B)(6) 2021. THE CASE WAS COMPLETED BY USING THE OTHER PLATE FROM THE TRAY.

  Patient problems: Insufficient Information

  MAUDE report 19228428 ↗
• InjurySep 5, 2018Device Dislodged or Dislocated

  IT WAS REPORTED VIA FACILITY MEDWATCH REPORT (B)(4) THAT THE PATIENT PRESENTED TO THE HOSPITAL FOR A DISPLACED PREVIOUS FIXATION ((B)(6) 2018) OF THE RIGHT DISTAL FIBULA AND REQUIRED REMOVAL OF DEEP IMPLANT FROM RIGHT ANKLE DISTAL FIBULA AND OPEN REDUCTION AND INTERNAL FIXATION OF RIGHT FIBULA. THE SURGEON DOCUMENTED THE PATIENT HAD RECEIVED THE SURGICAL FIXATION FOR THE PREVIOUS PROCEDURE THREE WEEKS PRIOR AND CURRENTLY HAD A POSTEROLATERAL DISLOCATION OF THE ANKLE AGAIN WITH CHOICE OF REVISION FIXATION. THE SURGEON'S DOCUMENTATION REVEALED THE PATIENT'S PREVIOUS PLATE DURING SURGERY WAS NOTED TO HAVE PULLED OFF THE FIBULA. THE DISTAL SCREWS AND FIBULA WERE THEN REMOVED AND WHEN PLATE WAS EXTRACTED, THE FRACTURE SITE WAS IDENTIFIED AND THE PROXIMAL FIBULA SHAFT IDENTIFIED. THE SURGEON ALSO DOCUMENTED THAT IMMEDIATELY DURING THE REVISION SURGERY, THE PATIENT WAS NOTED TO HAVE VERY GOOD SOFT TISSUE MEDIALLY WITH NO FRACTURE BLISTERS. NO OTHER COMPLICATIONS WERE REPORTED. ADDITIONAL INFORMATION OBTAINED 8/21/2018: THE FACILITY HAS CONFIRMED THAT THEY DO NOT HAVE ANY FURTHER INFORMATION WITH REGARD TO THE PART NUMBERS OF THE SCREWS THAT WERE EXPLANTED WITH THE 10 HOLE PLATE. A DIFFERE

  Patient problems: No Code Available

  MAUDE report 7846675 ↗