NA 04.033.032SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982270788), received between May 20, 2019 and May 20, 2019 — 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 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.

• MalfunctionMay 20, 2019Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT ON (B)(6) 2019, WHILE INSERTING THE TITANIUM CANNULATED FEMORAL RECON NAIL USING THE NEW PROXIMAL FEMORAL (PF) ENTRY FEMORAL RECON NAIL, THE SURGEON COULDN'T ADVANCE THE NAIL ALL THE WAY DOWN THE FEMUR. THE NAIL STOPPED ABOUT ONE (1) CM SHORT FROM WHERE IT NEEDED TO GO AND WOULDN'T ADVANCE ANY FURTHER. THE SURGEON HAD TO HIT THE RADIOLUCENT INSERTION HANDLE HARDER THAN USUAL THE DRIVING CAP/THREADED ENDED UP SNAPPING OFF INTO THE INSERTION HANDLE. THE SURGERY WAS COMPLETED USING AN OLDER STYLE PF NAIL RETROGRADE/ANTEGRADE FEMORAL NAIL. WHEN USING THE OLDER STYLE NAIL INSERTED IT WAS ALSO NOTICED THAT THE DEPTH GAUGE FOR LOCKING SCREWS WAS ALSO BENT. THEY USED A DIFFERENT DEPTH GAUGE TO COMPLETE THE SURGERY. THERE WAS A SURGICAL DELAY OF TWENTY-FIVE (25) MINUTES CAUSING MORE RADIATION TO THE PATIENT AND EVERYONE IN THE ROOM SINCE THEY HAD TO TAKE MORE THAN THE USUAL AMOUNT OF X-RAYS. PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT IS DOING FINE. CONCOMITANT DEVICE: RADIOLUCENT INSERTION HANDLE (PART 03.033.001, LOT L700498, QUANTITY 1). THIS REPORT IS FOR ONE (1) CANNULATED FEMORAL NAIL. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8624922 ↗