Arthrex® AR-8827-18Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867046771), received between Sep 6, 2024 and Apr 22, 2026 — classified as 3 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (2 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryApr 22, 2026Patient Device Interaction Problem

  ON 02-JAN-2025, A PATIENT CALLED IN REPORTING THAT AFTER UNDERGOING AN ANKLE PROCEDURE ON (B)(6) 2025, SHE HAD EXPERIENCED A REACTION, ALONG WITH EXPERIENCING HER SKIN CHANGING, AND PAIN NEAR HER ANKLE. ADDITIONAL INFORMATION WAS PROVIDED ON 24-MAR-2026 WHERE THE PATIENT REPORTED THAT SHE UNDERWENT A LEFT ANKLE PROCEDURE FOR A DISPLACED BIMALLEOLAR FRACTURE OF THE LOWER LEG ON (B)(6) 2025 WHERE AN AR-8943DL-04 LOCKING DISTAL FIBULA PLATE, AR-8827-18 LOW PROFILE SCREW¿, 2.7 X 18 MM, (3) AR-8827CL-12 KREULOCK¿ COMPRESSION SCREW, SS, 2.7 MM X 12 MM, AR-8827CL-14 KREULOCK¿ COMPRESSION SCREW, SS, 2.7 MM X 14 MM, (2) AR-8827CL-16 KREULOCK¿ COMPRESSION SCREW, SS, 2.7 MM X 16 MM, (3) AR-8835CL-12 KREULOCK¿ COMPRESSION SCREW, SS, 3.5 MM X 12 MM, AR-8835-14 LOW PROFILE SCREW¿, SS, 3.5 X 14 MM, CORTICAL, AND AN AR-8925SS SYNDESMOSIS TIGHTROPE® XP, STAINLESS STEEL WERE IMPLANTED. THE PATIENT BEGAN TO EXPERIENCE THE FOLLOWING SYMPTOMS ON (B)(6) 2025; RUNNY NOSE, DIARRHEA, BLURRED VISION, SENSITIVITY TO THE ANKLE, BOTTOM OF THE TOES ACHE, CHANGES IN SKIN, BLOOD PRESSURE GOING UP AND DOWN, BACK OF HEELS ACHE, ITCHY ANKLE; THAT IS BEING TREATED WITH A CREAM, SHARP PAIN IN THE ANKLE, RIGHT EAR BLOC

  Patient problems: Foreign Body Reaction; Pain

  MAUDE report 24956989 ↗
• InjuryJul 8, 2025Defective Device; Adverse Event Without Identified Device or Use Problem; Defective Device; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED ON 07/08/2025: THE AR-8973DS FIBULOCK IMPLANT SYSTEM HAD THE END CAP IN THE KIT INSERTED INTO THE FIBULOCK NAIL DURING THE INITIAL PROCEDURE. DURING THE ROH/TTC REVISION, THE END CAP WAS REMOVED BEFORE THE EXTRACTION OF THE BROKEN FIBULAR NAIL. THE END CAP FROM THE AR-8973DS FIBULOCK IMPLANT SYSTEM DID NOT BREAK DURING THE PROCEDURE.

  Patient problems: Bone Fracture(s); Failure of Implant

  MAUDE report 22439189 ↗
• InjurySep 6, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT A PATIENT UNDERWENT REVISION SURGERY DUE TO PAIN. ON (B)(6) 2023, THE PATIENT UNDERWENT SURGERY FOR AN ANKLE FRACTURE AND SYNDESMOSIS REPAIR. DURING THE PROCEDURE, TWO AR-8730-36PT LOW PROFILE SCREW, TI, 3.0 MM X 36 MM, CANCELLOUS, PARTIALLY THREADED, AN AR-8827-18 LOW PROFILE SCREW, 2.7 X 18 MM, CORTEX, AN AR-8827-22 LOW PROFILE SCREW, 2.7 X 22 MM, CORTEX, AN AR-8973DS FIBULOCK IMPLANT SYSTEM, AN AR-8973L-38-180 ARTHREX FIBULOCK NAIL, 3.8 X 180 MM LEFT, AND AN AR-8925SS SYNDESMOSIS TIGHTROPE XP, STAINLESS STEEL WERE IMPLANTED. POST-OPERATIVE, THE PATIENT STARTED TO EXPERIENCE PAIN. ON (B)(6) 2024, REVISION SURGERY WAS PERFORMED TO REMOVE ALL THE IMPLANTS EXCEPT FOR THE AR-8973L-38-180 ARTHREX FIBULOCK NAIL. DURING THE REMOVAL OF THE IMPLANTS, THE DISTAL END OF THE EXTRACTION TOOL OF AN AR-8973RK FIBULOCK REMOVAL KIT BROKE OFF AFTER ROUGHLY 8 MALLET STRIKES. ANOTHER AR-8973RK FIBULOCK REMOVAL KIT WAS OPENED, AND THE SAME THING OCCURRED. THE EXTRACTION TOOLS BROKE, BUT NO PIECES WERE IN THE PATIENT. THE SURGEON ELECTED TO CLOSE AND FINISH THE CASE WITH THE NAIL STILL IMPLANTED AND FELT CONFIDENT THAT THE REMOVE

  Patient problems: Pain

  MAUDE report 20156936 ↗