NA 04.033.039SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982270900), received between Mar 20, 2019 and Mar 20, 2019 — classified as 1 injury.

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.

• InjuryMar 20, 2019Break; Break

  UPDATED EVENT DESCRIPTION: IT WAS REPORTED THAT A PATIENT UNDERWENT REVISION ON (B)(6) 2019, THE TITANIUM CANNULATED FEMORAL RECON NAIL (FRN) WAS REMOVED DUE TO BREAKAGE AND POSSIBLY DELAYED HEALING. IT BROKE AT THE DISTAL TIP OF THE NAIL WHERE THE ANTERIOR-POSTERIOR (AP) SCREW IS(NO MALFUNCTION OF THE SCREW) AND A RETROGRADE FEMORAL NAIL WAS IMPLANTED. THE FRN WAS ORIGINALLY IMPLANTED TO THE PATIENT ON (B)(6) 2018. THERE WERE A SURGICAL DELAY OF THIRTY (30) MINUTES TO RETRIEVE THE DISTAL END OF THE BROKEN NAIL. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME WAS GOOD.

  Patient problems: No Code Available; Nonunion/Delayed-union Bone Fracture

  MAUDE report 8437242 ↗