NA 04.033.971SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982272355), received between Jun 30, 2020 and Jun 30, 2020 — classified as 1 injury.

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.

• InjuryJun 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2020, THE PATIENT WAS BROUGHT BACK TO THE OPERATING ROOM TO CORRECT THE MALROTATION OF THE LEFT FEMUR. INITIALLY, THE PATIENT WAS IMPLANTED WITH A FEMORAL RECON NAIL SYSTEM (FRNS) ON (B)(6) 2020. THE THREE (3) UNKNOWN SCREWS WERE REMOVED AND THE NAIL WAS EXTERNALLY ROTATED ALONG WITH THE DISTAL FEMUR. THE THREE (3) UNKNOWN SCREWS WERE REINSERTED INTO THE NAIL. ALL HARDWARE CAME OUT EASILY AND NOTHING WAS BROKEN. THERE WAS NO HARDWARE FAILURE AND NO X-RAYS ARE AVAILABLE. THE PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES FOUR (4) DEVICES. THIS REPORT IS FOR ONE (1) 9 MM / TI CANN FRN / GT 400MM / LEFT - STERILE. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 10214353 ↗