Arthrex® AR-1249TKRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867292260), received between Mar 14, 2022 and Mar 14, 2022 — classified as 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 14, 2022Break; Entrapment of Device

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT (ACL) RECONSTRUCTION SURGERY WITH BTB GRAFT + FASTTHREAD INTERFERENCE SCREWS, THE SURGEON USED THE INTERFERENCE SCREW INSERTION KIT TO INSERT THE FAST THREAD SCREW (9MM X 30MM). HE DID DRILL THE WIRE BEYOND THE DEPTH MARKING RELATIVE TO THE BLACK HANDLE ON THE INSERTION KIT DILATOR DEVICE. THE SURGEON WITHDREW THE SCREW DRIVER AND ATTACHED THE WIRE DRIVER TO REMOVE THE WIRE. THE TORSION MUST HAVE BROKEN THE WIRE. SURGEON TRIED TO PULL THE BROKEN PORTION OF THE WIRE DIRECTLY OUT WITH PLIERS. THIS PORTION OF WIRE BROKE AGAIN RESULTING IN THE REMINING PIECE REMAINING IN SITU WITHIN THE PATIENTS FEMUR. IT WAS DECIDED TO LEAVE IT AND COMPLETE THE CASE. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE WAS USED ANYWAY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 13757840 ↗