NA 04.033.967SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982272331), received between Apr 29, 2022 and Apr 29, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Difficult to Advance” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 29, 2022Difficult to Advance; Difficult to Advance

  IT WAS REPORTED ON (B)(6) 2022, DURING A ROUTINE FRN NAIL INSERTION, THE IM NAIL GOT STUCK IN THE CANAL OF THE FEMUR. THE CANAL 1.5MM REAMED OVER THE NAIL DIAMETER AND OPENED THE PROXIMAL SEGMENT WITH THE APPROPRIATE 14MM DRILL BIT FROM THE SET. THE NAIL BECAME INCARCERATED UPON INSERTION AND THE PROXIMAL BODY OF THE NAIL SEEMED TO BE TOO LONG FOR THE PROXIMAL SEGMENT OF THE FEMUR ON THIS PATIENT. THE DRIVING CAP BROKE OFF LEAVING A FRAGMENT IN THE INSERTION HANDLE DUE TO INCARCERATION THAT LED THE SURGEON TO HAVE TO STRIKE THE INSERTION HANDLE TO SEAT THE NAIL. THE SURGEON DETERMINED THAT THE NAIL WAS FINALLY SEATED TO A DEPTH AFTER A 30 MIN DELAY. STANDARD LOCKING OF THE PROXIMAL AND DISTAL NAIL OCCURRED WITHOUT INCIDENT. THIS REPORT IS FOR ONE (1) 9 / TI CANN FRN / GT 360 / LEFT - SILE. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14254562 ↗