Arthrex® AR-8967-2895Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867056527), received between Jun 2, 2017 and Jun 2, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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.

• InjuryJun 2, 2017Fracture; Loose or Intermittent Connection; Device Dislodged or Dislocated

  IT WAS REPORTED BY A PATIENT THAT ON (B)(6) 2015 SHE HAD UNDERGONE A RIGHT ANKLE FUSION PROCEDURE DURING WHICH AN ARTHREX AR-8943BR-06 LOCKING DISTAL FIBULA PLATE AND THE FOLLOWING SCREWS WERE IMPLANTED: AR-8827L-24, AR-8835L-32, AR-8835L-40, AR-8935L-45, AR-8967-2870, AR-8967-2895, AR-8967-28105, AR-8840CL-40, AR-8835L-14 AND AR-8827L-30 (QTY 3). PATIENT REPORTS THE AR-8943BR-06 PLATE (CC103533 LINE 179935) SNAPPED INTO TWO PIECES ON (B)(6) 2016 WHICH RESULTED IN SEVERAL SCREWS ALSO BEING RELEASED. PATIENT REPORTS THE PLATE AND MULTIPLE SCREWS ARE NOW LOOSE WITHIN THE TISSUE OF THE PATIENT'S FOOT. THIS WAS CONFIRMED BY A CT SCAN ON (B)(6) 2016. WHEN THE PLATE SNAPPED, THE RECONSTRUCTED FOOT AND ANKLE COLLAPSED CAUSING THE PATIENT INTENSE AND CONSTANT PAIN WHICH ALSO RESULTED IN SEVERE LIMITS ON HER MOBILITY, EVEN WITH USE OF HER CUSTOM ORTHOTIC BOOT. THE SURGEON WANTS PATIENT NON-WEIGHT BEARING AND OFF OF THE FOOT TOTALLY AND HAS REQUESTED AN ELECTRIC MOBILITY SCOOTER FOR PATIENT TO USE FULL TIME. PATIENT ALSO STATES THAT THE SURGEON IS RELUCTANT TO ATTEMPT TO REMOVE THE LOOSE PLATE AND SCREWS OR REDO THE SURGERY FOR FEAR OF CAUSING EVEN MORE DAMAGE TO HEALTHY TISSUE AND HEALING T

  Patient problems: Ambulation or Postural Difficulties; Failure of Implant; Limited Mobility Of The Implanted Joint; Pain

  MAUDE report 6607828 ↗