Arthrex® AR-8835CL-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888867323155), received between Feb 2, 2024 and Apr 22, 2026 — classified as 4 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (3 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 4 most recent of 4 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 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 24957140 ↗
• 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 24957131 ↗
• 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 24957124 ↗
• InjuryFeb 2, 2024Break; Break

  ON 01/23/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT A PATIENT UNDERWENT A CLAVICLE FRACTURE PROCEDURE ON (B)(6) 2023 WHERE AN AR-2652CL CLAVICLE FRACTURE PLATE, AN AR-8835-14 LOW PROFILE SCREW, (2) AR-8835-16 LOW PROFILE SCREWS, AN AR-8835CL-12 KREULOCK COMPRESSION SCREW, (2) AR-8835CL-14 KREULOCK COMPRESSION SCREWS, AN AR-8835-10 LOW PROFILE SCREW, AN AR-7268 FIBERTAPE® CERCLAGE WITH TIGERLINK, AND AN AR-7268T TIGERTAPE® CERCLAGE WITH FIBERLINK WERE IMPLANTED. FIVE WEEKS POST-OP, THE PATIENT REPORTED HEARING OR FEELING A POP. AN X-RAY WAS TAKEN THAT CONFIRMED THAT THE AR-2652CL PLATE HAD BROKEN. ON (B)(6) 2024, A REVISION SURGERY WAS PERFORMED WHERE THE IMPLANTED DEVICES WERE REMOVED. THE REVISION WAS COMPLETED USING A DEVICE FROM ANOTHER MANUFACTURER.

  Patient problems: Failure of Implant

  MAUDE report 18635142 ↗