Arthrex® AR-1407Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867016668), received between May 8, 2019 and Jun 18, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 18, 2024Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT THE DEVICE IS DULL. THERE WAS NO HARM OR ADVERSE EVENT FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19563895 ↗
• InjuryMay 8, 2019Break; Entrapment of Device

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT (ACL) PROCEDURE THAT AN AR-1407 (7MM CANNULATED HEADED REAMER) WAS USED. IT WAS INDICATED THAT MATERIAL BROKE OFF FROM THE INSTRUMENT AND REMAINS IN THE PATIENT. THE SURGERY WAS FINISHED WITH A NEW DEVICE WITH A DIFFERENT PART NUMBER, AR-1408. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. UPDATE 18-APR-2019: ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT PART AR-1887-08P (TRANSFIX TUNNEL HOOK 7) WAS ALSO INVOLVED IN THIS INCIDENT. THIS DEVICE IS NOT APPROVED FOR SALE IN THE USA. UPDATE 29-APR-2019: THE HEAD OF THE DEVICE AR-1887-08P, WHICH ACTUALLY SHOULD PULL THE WIRE OUT, DID NOT COME OUT, HENCE IT BROKE OFF. IT WAS A DEVICE WHICH HAS BEEN USED VERY RARE AND WHICH HAS BEEN CONTROLLED ROUTINELY. SINCE THIS INCIDENT SENSITIVE CONTROLS HAVE BEEN INITIATED. A DROPPING OR ANY OTHER MISUSE OF THE AFFECTED DEVICE CANNOT BE DETECTED. THE LOOP OF THIS DEVICE REMAINED INSIDE THE PATIENT. IT WAS NOTED THAT IT CAN ONLY BEEN REMOVED WITH HIGH TECHNICAL EFFORT AND THAT LEAVING IT REMAINING INSIDE THE PATIENT CAN BE EXPECTED TO HAVE NO FURTHER CONSEQUENCES. HENCE THE PART HAS REMAINED INSIDE THE PATIENT. AF

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8591600 ↗