CrossFT CFK-475DTRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10845854606193), received between Sep 23, 2021 and Sep 23, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Fragmentation” (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.

• MalfunctionSep 23, 2021Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE CFK-475DT WAS USED DURING A ROTATOR CUFF REPAIR ON (B)(6) 2021 WHEN IT WAS REPORTED ¿SURGEON WAS INSERTING CROSS FT KNOTLESS CFK-475DT FOR LATERAL ROW, AND TIP OF ANCHOR BROKE OFF. I WAS PRESENT AT THE CASE BUT HAD STEPPED OUT OF THEATRE TO FIND ALTERNATIVE SOLUTION AS THE PATIENT HAD SOFT BONE AND THE PREVIOUS ANTERIOR LATERAL ROW ANCHOR HAD PULLED OUT (SAME ONE WAS RE-LOADED AND RE-INSERTED), AND THE SURGEON WANTED AN ALTERNATIVE. LARGE, MALE PATIENT - OVER 6 FOOT.¿. IT WAS REPORTED THAT THE FRAGMENT WAS RETRIEVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE DEVICE AFTER A 2-MINUTE DELAY. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12518047 ↗