Arthrex® AR-2254RRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867026247), received between Sep 18, 2019 and Jul 1, 2020 — classified as 2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 1, 2020Break

  IT WAS REPORTED THAT THE HEAD OF THE DEVICE BROKE OFF DURING AN ACROMIO CLAVICULAR DISLOCATION SURGERY. THE BROKEN PIECE WAS RETRIEVED FROM THE PATIENT'S BODY. ACCORDING TO THE REPORTER, THE SURGICAL TECHNIQUE HAD TO BE CHANGED BUT NO DETAILS WERE GIVEN WHAT HAD TO BE CHANGED AND THE FOLLOWING WAS REPORTED: "UNUSABLE MATERIAL HAS TO BE REPLACED BY ANOTHER SYSTEM WHOSE SECONDARY ABLATION WILL BE NECESSARY". UPDATE 22-JUNE-2020: THE FOLLOWING INFORMATION HAS BEEN MADE AVAILABLE TODAY: IT WAS IMPOSSIBLE TO PUT ON THE ENDO-BUTTON, SO THE SURGEON PUT A PIN TO HOLD THE COLLARBONE IN PLACE IN FRONT OF THE SCAPULAR. THE SURGERY TOOK APPROX. 30 - 45 MIN LONGER THAN EXPECTED DUE TO THIS INCIDENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10217860 ↗
• InjurySep 18, 2019Break

  IT WAS REPORTED THAT THE DEVICE BROKE. THE EXTREMITY DISSOCIATED FROM THE REST OF THE VIEWFINDER WHEN IT WAS PUT IN PLACE FOR ARTHROSCOPIC ACROMIOCLAVICULAR DYSJUNCTION INTERVENTION. BROKEN PIECE WAS RETRIEVED FROM PATIENT. NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY WAS REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY. UPDATE 28-AUG-2019: SURGEON HAD TO CHANGE SURGICAL TECHNIQUE. THE PLANNED TECHNIQUE WAS ARTHROSCOPIC ACROMIO CLAVICULAR DYSJUNCTION. BECAUSE OF THE INCIDENT, THE SURGEON HAD TO CHANGE HIS INTERVENTION TO AN OPEN PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9081026 ↗