Arthrex® AR-2657DLRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888867027527), received between Dec 7, 2020 and Mar 3, 2026 — classified as 1 injury, 3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 3, 2026Fracture

  IT WAS REPORTED THAT ON (B)(6) 2026, A FOLLOW-UP X-RAY REVEALED THAT THE IMPLANTED PLATE HAD FRACTURED WITHOUT ANY TRAUMA. THE SURGERY HAD TAKEN PLACE APPROXIMATELY TWO WEEKS PRIOR. NO FURTHER INFORMATION IS AVAILABLE. UPDATE 12-FEB-2026 - FURTHER INFORMATION WAS RECEIVED: IT WAS REPORTED THAT ON (B)(6) 2026, A FOLLOW-UP X-RAY REVEALED THAT THE IMPLANTED PLATE HAD FRACTURED WITHOUT ANY TRAUMA. THE PATIENT IS CURRENTLY ONLY REPORTING SYMPTOMS RESULTING FROM THE SURGICAL PROCEDURE. NO REVISION SURGERY IS CURRENTLY PLANNED; CONSERVATIVE TREATMENT IS BEING PURSUED, WHICH IS WHY THE PLATE REMAINS IN THE PATIENT. THE PATIENT ORIGINALLY UNDERWENT SURGERY ON (B)(6) 2026, FOR A CLAVICLE FRACTURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 24494889 ↗
• MalfunctionJun 19, 2024Break; Break

  IT WAS REPORTED THAT DURING A CLAVICLE FRACTURE SURGERY WHILE BENDING THE PLATE IT CRACKED. NOTHING BROKE OFF FROM THE DEVICE. ACCORDING TO THE SURGEON THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. 16-MAR-2022 UPDATE DW FURTHER INFORMATION WERE PROVIDED THAT THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19567137 ↗
• InjuryJan 3, 2023Break

  IT WAS REPORTED THAT THE PLATE HAS BROKEN MEDIALLY, THROUGH THE SUTURE AND SCREW HOLES. PATIENT DID NOT FALL TO CAUSE BREAKAGE. PLATE WAS IMPLANTED ON (B)(6) 2022. SECOND SURGERY WAS DONE ON (B)(6) 2022. NO FURTHER INFORMATION RECEIVED.

  Patient problems: Failure of Implant

  MAUDE report 16086407 ↗
• MalfunctionDec 7, 2020Break

  IT WAS REPORTED THE CLAVICULA PLATE BROKE 8 WEEKS POST OP. ACCORDING TO THE SURGEON, PATIENT WAS ACTIVELY WORKING IN THE GARDEN. REVISION SURGERY WAS PERFORMED ON (B)(6) 2020, DURING THE REVISION, THE FRACTURE ZONE WAS REFRESHED AND FILLED UP WITH ILIAC CREST SPONGIOSA AND FIXATED WITH AN ARTHREX 10 HOLE PLATE.

  Patient problems: Insufficient Information

  MAUDE report 10962234 ↗