Arthrex® AR-2658TRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867183841), received between Nov 29, 2016 and Nov 29, 2016 — classified as 1 injury.

The most frequently reported specific device problem is “Material Separation” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryNov 29, 2016Material Separation

  IT WAS REPORTED THAT THE DISTAL CLAVICLE REPAIR ASSEMBLY, AR-2658T, LOT 10031529 ((B)(4)), WAS BEING USED FOR A DISTAL CLAVICLE AND AC REPAIR PROCEDURE ON (B)(6) 2016. THE AR-2658T INCLUDES A PRELOADED CLAVICLE BUTTON FOR THE SUPERIOR PORTION OF THE PLATE. ALSO USED WITH THE CONSTRUCT WAS AN AR-2270, LOT 10039252, DOG BONE BUTTON ((B)(4)) WHICH WAS ATTACHED TO THE CONSTRUCT AND EVERYTHING WAS TIGHTENED TO REDUCE THE SEPARATION. THE PILOT HOLES FOR THE SCREWS WERE CREATED BY A 3.0 MM CANNULATED DRILL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. A FEW DAYS AFTER THE SURGERY, THE SUTURE PULLED OUT OF THE TIGHTROPE. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2016 TO REMOVE ALL PIECES OF THE IMPLANT ASSEMBLY. THE SUTURE AND BOTH BUTTONS WERE ALSO RETRIEVED FROM THE PATIENT. A THIRD SURGERY WILL BE NECESSARY TO REDUCE AC AFTER THE CLAVICLE IS HEALED. BONE QUALITY: SLIGHTLY NECROTIC.

  Patient problems: Necrosis

  MAUDE report 6132352 ↗