Arthrex® AR-8827CL-16Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867324206), received between Jun 7, 2024 and Apr 22, 2026 — classified as 2 injuries, 1 malfunction.

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 18, 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 24957146 ↗
• InjuryApr 22, 2026Patient Device Interaction Problem

  ON 02-JAN-2025, A PATIENT CALLED IN REPORTING THAT AFTER UNDERGOING AN ANKLE PROCEDURE IN (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 IN (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 24957127 ↗
• MalfunctionJun 7, 2024Use of Device Problem; Use of Device Problem

  IT WAS REPORTED ON 08/25/2022 BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-8827CL-16 KREULOCK SCREW WOULD NOT SCREW INTO PLATE. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19487710 ↗