NA 458.950SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982230966), received between May 30, 2018 and May 30, 2018 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMay 30, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) TO TREAT A FEMUR FRACTURE ON AN UNKNOWN DATE. PATIENT WAS IMPLANTED WITH TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) CONSISTING OF A NAIL, HELICAL BLADE AND TWO 5.0MM LOCKING SCREWS. PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2018 TO REMOVE THE TFNA CONSTRUCT AND REPLACE IT WITH A TOTAL HIP DUE TO ARTHRITIS. THERE WAS NO ISSUE WITH THE NAIL, HELICAL BLADE OR LOCKING SCREWS. THE HARDWARE WAS REMOVED WITHOUT INCIDENT OR SURGICAL DELAY. ROUTINE INTRAOPERATIVE X-RAYS STANDARD FOR THE PROCEDURE WERE TAKEN. EXPLANTED HARDWARE WAS DISCARDED BY THE HOSPITAL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THE PATIENT WAS REPORTED AS STABLE. THIS REPORT IS FOR A 5.0MM TI LOCKING SCREW 50MM- FOR IM NAILS-STERILE. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: Arthritis; No Code Available

  MAUDE report 7554690 ↗
• InjuryMay 30, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) TO TREAT A FEMUR FRACTURE ON AN UNKNOWN DATE. PATIENT WAS IMPLANTED WITH TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) CONSISTING OF A NAIL, HELICAL BLADE AND TWO 5.0MM LOCKING SCREWS. PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2018 TO REMOVE THE TFNA CONSTRUCT AND REPLACE IT WITH A TOTAL HIP DUE TO ARTHRITIS. THERE WAS NO ISSUE WITH THE NAIL, HELICAL BLADE OR LOCKING SCREWS. THE HARDWARE WAS REMOVED WITHOUT INCIDENT OR SURGICAL DELAY. ROUTINE INTRAOPERATIVE X-RAYS STANDARD FOR THE PROCEDURE WERE TAKEN. EXPLANTED HARDWARE WAS DISCARDED BY THE HOSPITAL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THE PATIENT WAS REPORTED AS STABLE. THIS REPORT IS FOR A 5.0MM TI LOCKING SCREW 50MM- FOR IM NAILS-STERILE. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: Arthritis; No Code Available

  MAUDE report 7554680 ↗