NA 04.033.139SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982272546), received between May 18, 2020 and May 18, 2020 — classified as 1 injury.

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.

• InjuryMay 18, 2020Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT HAD BILATERAL MIDSHAFT FEMUR FRACTURES. ON (B)(6) 2020 A SURGERY WAS PERFORMED WITH BILATERAL, ANTEGRADE INTRAMEDULLARY NAILS. THE SURGEON STARTED ON THE LEFT FEMUR FIRST, THE PROXIMAL FEMUR WAS OPENED AND THE CANAL WAS REAMED TO 12.5MM AND PROXIMALLY TO 14MM TO ACCOMMODATE AN 11 MM X 380MM LEFT FEMORAL RECON NAIL. THE NAIL WAS INSERTED USING STANDARD TECHNIQUE AND APPROXIMATELY TWO (2) TO THREE (3) INCHES FROM FINAL PLACEMENT DEPTH, THE NAIL WOULD NO LONGER ADVANCE. THE SURGEON USED TYPICAL FORCE TO ADVANCE THE NAIL TO ITS FINAL POSITION, BUT IT WOULD NOT GO ANY FURTHER. A SERIES OF AP AND LATERAL X-RAYS WERE TAKEN TO MAKE SURE NOTHING WAS IMPEDING THE NAIL PATH, AND NOTHING WAS FOUND. THE SURGEONS DECIDED TO REMOVE THE NAIL WHICH TOOK AN EXTRAORDINARY AMOUNT OF FORCE TO REMOVE AND ADDED TIME TO THE PROCEDURE. THE NAIL WAS REMOVED, AND THE SURGEON DECIDED TO REAM THE CANAL TO A LARGER DIAMETER. THE CANAL WAS THEN REAMED TO 13.5 MM AND THE NAIL WAS RE-INSERTED. THE NAIL STOPPED ADVANCING IN THE SAME SPOT, AS IT HAD THE FIRST TIME. EVEN WITH HEAVY IMPACTION, IT WOULD NOT ADVANCE ANY FURTHER. THE SURGEONS DECIDED TO REMOVE THE NAIL WHI

  Patient problems: No Code Available

  MAUDE report 10065329 ↗