Arthrex® AR-8943BR-06Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867052574), received between Jun 2, 2017 and Mar 13, 2019 — classified as 2 injuries.

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

• InjuryMar 13, 2019Patient-Device Incompatibility; Patient Device Interaction Problem; Patient-Device Incompatibility; Patient Device Interaction Problem

  IT WAS REPORTED BY A PATIENT THAT SHE HAD UNDERGONE ANKLE SURGERY ON (B)(6) 2013 DURING WHICH TIME ARTHREX DEVICES WERE IMPLANTED. PATIENT MAY POSSIBLY BE HAVING AN ALLERGIC REACTION TO THE IMPLANT MATERIALS AND WAS INQUIRING ABOUT THE MATERIAL COMPOSITION. AT TIME OF INITIAL REPORT PATIENT DID NOT HAVE THE SPECIFIC PRODUCT NUMBERS OF HER IMPLANTS. PATIENT DOES NOT HAVE AN ALLERGY TO METAL BUT DOES HAVE ALLERGIES TO AT LEAST ONE COMPONENT OF TITANIUM, WHICH IS VANADIUM. ADDITIONAL INFORMATION OBTAINED 2/18/19: THE PROCEDURE ON (B)(6) 2013 WAS TO REPAIR AND ANKLE FRACTURE. THE PATIENT'S SYMPTOMS BEGAN SEVERAL MONTHS AFTER SURGERY. THE AREA AROUND THE SURGICAL SITE BECAME SWOLLEN WITH SKIN DISCOLORATIONS AS WELL AS TEXTURE WHICH CONTINUE SEVERAL YEARS POST OP. PATIENT HAS FREQUENT FEELINGS OF STIFFNESS AND PRESSURE IN THE AREA AS WELL. PATIENT HAS BEEN TREATED WITH MOBIC (NON-STEROIDAL ANTI-INFLAMMATORY DRUGS). MATERIAL COMPOSITION OF THE IMPLANTED DEVICES, WHICH ARE COMPRISED OF STAINLESS STEEL AND MEET ASTM STANDARDS, HAS BEEN PROVIDED TO THE PATIENT. THE FOLLOWING DEVICES WERE IMPLANTED DURING THE (B)(6) 2013 PROCEDURE: AR-8943BR-06, LOCKING DISTAL FIBULA PLATE, RIGHT 6 HOLE (QTY

  Patient problems: Hypersensitivity/Allergic reaction; No Code Available; Skin Discoloration; Swelling

  MAUDE report 8417382 ↗
• InjuryJun 2, 2017Collapse; Loose or Intermittent Connection

  IT WAS REPORTED BY A PATIENT THAT ON 12/9/15 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 ((B)(4)) 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 THAT HAS TAKEN PLAC

  Patient problems: Limited Mobility Of The Implanted Joint; Pain

  MAUDE report 6607827 ↗