Arthrex® AR-1318FT-40-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867287068), received between May 15, 2023 and Apr 11, 2024 — classified as 2 malfunctions.

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 18, 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.

• MalfunctionApr 11, 2024Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping

  IT WAS REPORTED THAT WHEN UNPACKING THE ANCHOR, IT WAS NOTICED THAT IT IS DEFECTIVE AND THEREFORE IT COULD NOT BE INSTALLED. THIS WAS NOTICED DURING SURGERY. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. UPDATE SWIT 15-JUL-2022: THE ANCHOR WAS IN THE PACKAGING WHEN IT WAS NOTICED THAT IT WAS ALREADY FALLEN OFF THE HANDLE AND COULD NOT BE PUT ON IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19089565 ↗
• MalfunctionMay 15, 2023Break; Break

  IT WAS REPORTED THAT DURING A THIRD PHALANX MIDDLE JOINT PLASTICS OF THE LIGAMENTS AN ISSUE WITH THE REPORTED DEVICE OCCURRED. AFTER THE ANCHOR WAS FULLY INSERTED THE INSERTER WAS TAKEN OFF THE ANCHOR BUT THE SUTURES GOING THROUGH THE INSERTER STUCK TOGETHER WITH THE LITTLE PART OF THE END OF THE INSERTER. WHILE THE SURGEON HAS HANDLING THE ISSUE THE METAL PART OFF THE INSERTER BROKE OFF. DUE TO THIS FAILURE THE NEEDLES WERE CUT OF AS THE COULD NOT BE USED ANYMORE. THE SURGEON WAS NOT ABLE TO RELEASE THE SUTURES FROM THE METAL PART AND THEREFORE RETRIEVED THE SUTURES INCLUDING THE BROKEN METAL PIECE BUT THE ANCHOR REMAINED IN THE PATIENT. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH ADDITIONAL NEEDLES BUT IT WAS ALSO REPORTED THAT THE ANCHOR WAS INSERTED BUT WITH INSUFFICIENT RESULT.. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 16929428 ↗