Arthrex® AR-8835CL-14Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888867323162), received between Feb 2, 2024 and May 12, 2025 — classified as 4 injuries.

The most frequently reported specific device problem is “Break” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMay 12, 2025Use of Device Problem; Use of Device Problem

  ON 3/31/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT A PATIENT'S CLAVICLE FRACTURE PLATE BROKE. NO FURTHER INFORMATION WAS PROVIDED. ON (B)(6) 2025, A PATIENT¿S LEGAL REPRESENTATIVE REPORTED VIA EMAIL THAT A CLAVICLE PLATE FRACTURED. THE PLATE WAS IMPLANTED DURING AN OPEN REDUCTION INTERNAL FIXATION OF THE RIGHT CLAVICLE PERFORMED ON (B)(6) 2024. ON (B)(6) 2024, IMAGING SHOWED A BENT CLAVICLE PLATE. ON (B)(6) 2024, IMAGING SHOWED A FRACTURED CLAVICLE PLATE. ON (B)(6) 2025, THE PATIENT UNDERWENT A PROCEDURE TO REMOVE THE HARDWARE. THE RECORDS INDICATED PATIENT NONCOMPLIANCE WITH POSTOPERATIVE PROTOCOL CONTRARY TO THE CLAVICLE PLATE'S DIRECTIONS FOR USE.

  Patient problems: Failure of Implant

  MAUDE report 22002529 ↗
• InjuryMay 12, 2025Use of Device Problem; Use of Device Problem

  ON (B)(6) 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT A PATIENT'S CLAVICLE FRACTURE PLATE BROKE. NO FURTHER INFORMATION WAS PROVIDED. ON (B)(6) 2025, A PATIENT¿S LEGAL REPRESENTATIVE REPORTED VIA EMAIL THAT A CLAVICLE PLATE FRACTURED. THE PLATE WAS IMPLANTED DURING AN OPEN REDUCTION INTERNAL FIXATION OF THE RIGHT CLAVICLE PERFORMED ON (B)(6) 2024. ON (B)(6) 2024, IMAGING SHOWED A BENT CLAVICLE PLATE. ON (B)(6) 2024, IMAGING SHOWED A FRACTURED CLAVICLE PLATE. ON (B)(6) 2025, THE PATIENT UNDERWENT A PROCEDURE TO REMOVE THE HARDWARE. THE RECORDS INDICATED PATIENT NONCOMPLIANCE WITH POSTOPERATIVE PROTOCOL CONTRARY TO THE CLAVICLE PLATE'S DIRECTIONS FOR USE.

  Patient problems: Failure of Implant

  MAUDE report 22002433 ↗
• 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 18636096 ↗
• 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 18635465 ↗