Arthrex® AR-13226Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867010116), received between Oct 6, 2020 and Feb 9, 2024 — classified as 2 malfunctions.

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.

• MalfunctionFeb 9, 2024Break; Break

  ON 1/23/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-13226 BB TAK TIP BROKE OFF UNDER AN AR-8958-01 TWO-HOLE PLATE DURING THE REMOVAL OF THE AR-13226 BB TAK. THIS ISSUE DID NOT DELAY THE CASE AS IT WILL STAY IN UNTIL THE AR-8958-01 TWO-HOLE PLATE FOR THE MAISONNEUVE IS REMOVED. THE SURGEON DID NOT APPEAR TO LEVERAGE THE TIP OF THE AR-13226 BB TAK ON THE AR-8958-01 TWO-HOLE PLATE. THIS WAS DISCOVERED DURING A MAISONNEUVE FRACTURE PROCEDURE (B)(6) 2024.

  Patient problems: Foreign Body In Patient

  MAUDE report 18680409 ↗
• MalfunctionOct 6, 2020Break; Difficult to Remove

  IT WAS REPORTED THAT DURING A CLAVICULA FRACTURE SURGERY WHILE THE SURGEON TRIED TO DRAW OUT THE BB-TAK WITH A PLIERS IT BROKE OFF AND 3 MM REMAINED INSIDE THE PATIENT. THE SURGEON DECIDED THAT THE SMALL FRAGMENT DOES NOT HAVE AN IMPACT ON THE PATIENT AND THEREFORE FINISHED THE SURGERY.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10634173 ↗