Arthrex® AR-2654CLRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888867027466), received between Feb 10, 2017 and Oct 24, 2024 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 24, 2024Failure to Advance; Failure to Advance

  ON 10/7/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-2654CL CLAVICLE FRACTURE PLATE THREADS WERE STRIPPED. THE SURGEON COULDN¿T SCREW IN THE LOCKING TOWER TO THE PLATE OR THE BENDING RODS TO ADJUST THE PLATE. THIS WAS DISCOVERED DURING A CLAVICLE FRACTURE PROCEDURE ON (B)(6) 2024. ADDITIONAL INFORMATION RECEIVED ON 10/21/2024: A SECOND AR-2654CL CLAVICLE FRACTURE PLATE FROM A DIFFERENT LOT NUMBER WAS USED TO COMPLETE THE CASE. THE CASE WAS DELAYED BETWEEN FIVE TO TEN MINUTES. THIS WAS IN THE MIDDLE OF THE CASE SO ADDITIONAL ANESTHESIA WAS ADMINISTERED SINCE THE PATIENT WAS STILL ASLEEP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20524434 ↗
• InjuryAug 31, 2023Break; Break

  IT WAS REPORTED THAT THERE WAS A PROBLEM WITH A CLAVICULAR PLATE. AT 6 WEEKS AFTER THE INITIAL SURGERY THE PLATE FRACTURED. THIS LED TO RECURRENT PAIN, BONE DEFORMATION AND SURGICAL RESUMPTION. THE PLATE WAS REMOVED AND A NEW ONE WAS PUT IN PLACE. NO FURTHER INFORMATION RECEIVED.

  Patient problems: Failure of Implant

  MAUDE report 17665353 ↗
• InjuryJul 6, 2023Break; Break

  ON 06/12/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-2654CL CLAVICLE PLATE SNAPPED IN HALF. THIS WAS DISCOVERED DURING A REVISION SURGERY, CLAVICLE WAS A REFRACTURE CAUSING THE NEED FOR THE REVISION SURGERY TO OCCUR.

  Patient problems: Bone Fracture(s)

  MAUDE report 17271915 ↗
• MalfunctionOct 12, 2021Break; Fracture

  IT WAS REPORTED THAT AFTER A INITIAL SURGERY ON (B)(6) 2021 THE PLATE BROKE INTO TWO PIECES ON (B)(6) 2021. THE PATIENT REPORTED THAT NO SPECIAL MOVEMENT WAS DONE. 21-SEP-2021 UPDATE: FURTHER INFORMATION WERE PROVIDED THAT THE INITIAL SURGERY WAS A PLATING OF A FRACTURE OF THE CLAVICULA. 22-SEP-2021 UPDATE: FURTHER INFORMATION WERE PROVIDED THAT THE REVISION WAS PERFORMED TO RETRIEVE THE BROKEN PLATE AND THE THAT THE SURGEON HAS TREATED THE PATIENT WITH A NEW PLATE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12615082 ↗
• InjuryFeb 10, 2017Bent

  IT WAS REPORTED THAT THE PATIENT HAD A PRIMARY CLAVICLE PROCEDURE IN (B)(6) 2016 WITH AN ARTHREX CLAVICLE PLATE, AND IT WAS SUCCESSFUL. TWO MONTHS POST-OP, IMAGING WAS PERFORMED AND SHOWED THAT THE CLAVICLE PLATE WAS BENT. THE SURGEON DECIDED TO LEAVE IT IN TO GIVE IT TIME TO HEAL. THE CLAVICLE PLATE WAS REMOVED ON (B)(6) 2017. THE PLATE WAS BENT, AND THE PATIENT HAD A NON-UNION. THE SURGEON USED ANOTHER MANUFACTURER'S PLATE TO COMPLETE THIS PROCEDURE SUCCESSFULLY.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 6321832 ↗