NA 04.045.058Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982292926), received between Oct 20, 2022 and Oct 20, 2022 — classified as 1 injury.

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. 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.

• InjuryOct 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS SUBMITTED AS PART OF AN INVESTIGATOR INITIATED STUDY (IIS) FOR THE RETROGRADE FEMORAL NAIL ADVANCED (RFNA). IT WAS REPORTED THAT A PATIENT WAS PRESENTED AFTER A MOTOR VEHICLE CRASH WITH A LEFT OPEN DISTAL FEMUR FRACTURE ON (B)(6) 2021 AND WAS OPERATED ON WITH RFNA INTRAMEDULLARY NAIL ON JUNE 24, 2021. PATIENT WAS DIAGNOSED WITH INFECTION OF HER HARDWARE/SEPTIC NONUNION ON (B)(6) 14, 2021. PATIENT UNDERWENT DEBRIDEMENT AND EXCHANGE OF HARDWARE ON (B)(6) 2021. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) LOCKING SCREW FOR IM NAIL Ø 5MM/ 58MM/ XL25 THIS IS REPORT 3 OF 8 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture; Unspecified Infection

  MAUDE report 15643854 ↗

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