NA 04.045.066Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982292964), received between Mar 24, 2022 and Jul 23, 2024 — classified as 3 injuries.

The most frequently reported specific device problem is “Migration” (3 reports).

2 other recalls cover devices cleared under the same FDA submission (K201336, K201346); they may or may not involve this specific model.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJul 23, 2024Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2024 PATIENT WAS BROUGHT INTO SURGERY BY SURGEON FOR A LOOSENING OF DISTAL INTERLOCKING SCREWS IN A SYNTHES RFNA FEMORAL NAIL. THE IMPLANT WAS INITIALLY PLACED BY SURGEON ON (B)(6) 2024 AT THE SAME FACILITY. AT SOME POINT AFTER THAT DATE THE PATIENTS NURSING HOME NOTICED PROMINENT HARDWARE AT THE SKIN. THE PATIENT WAS BROUGHT TO THE HOSPITAL FOR REVISION SURGERY ON (B)(6) 2024. THERE WAS AN INFECTION. THERE WAS NO SURGICAL DELAY. THIS REPORT INVOLVES ONE (1) LOCKING SCREW FOR IM NAIL Ø 5MM/ 66MM/ XL25. THIS IS REPORT 2 OF 6 FOR (B)(4)

  Patient problems: Unspecified Infection

  MAUDE report 19806114 ↗
• InjuryApr 4, 2022Migration; Migration

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE USA AS FOLLOWS: IT WAS REPORTED THIS MORNING, (B)(6) PERFORMED REVISION SURGERY ON A TIBIAL NAIL ADVANCED, REMOVING A 66MM 5.0 LOCKING SCREW (04.045.066) THAT HAS BACKED OUT OF THE NAIL, CLOSE TO BREAKING THROUGH SKIN. THE SCREW WAS REMOVED FROM THE ANTERIOR TUBERCLE HOLE PROXIMALLY. NO ADDITIONAL STEPS WERE PERFORMED ONCE SCREW WAS REMOVED. THE TNA WAS FIRST IMPLANTED 6 WEEKS AGO. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THIS REPORT IS FOR ONE (1) LOCKING SCREW FOR IM NAIL 5/ 66/ XL25. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 13994807 ↗
• InjuryMar 24, 2022Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2022 THE PATIENT UNDERWENT A REVISION OF RETROGRADE FEMORAL NAILING-ADVANCED SYSTEM (RFNA) DUE TO THREE (3) SCREWS BACKING OUT IN THE DISTAL PORTION OF THE NAIL. ALL SCREWS WERE REMOVED. A DISTAL FEMUR PLATE WAS ADDED FOR FIXATION OF THE FRACTURE AND THE NAIL WAS LEFT IN AS WELL. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) LOCKING SCREW FOR IM NAIL Ø 5MM/ 66MM/ XL25. THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 13892565 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K201336, K201346. One submission often covers many models, so check the product and lot details in each record.

• Z-0228-2026 · Sep 26, 2025 · Open, Classified
  LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 46MM / XL25/ STER. Product Code: 04.045.346TS. Used in RFN-ADVANCEDTM Retrograde Femoral Nailing (RFNA) System and the Tibial Nail Adva
• Z-0229-2026 · Sep 26, 2025 · Open, Classified
  LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 42MM / XL25/ STER. Product Code: 04.045.342TS. Used in RFN-ADVANCEDTM Retrograde Femoral Nailing (RFNA) System and the Tibial Nail Adva