NA 04.045.074Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982293008), received between Mar 18, 2022 and Oct 20, 2022 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Migration” (2 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. 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 4 most recent of 4 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 (B)(6) 2021. PATIENT WAS DIAGNOSED WITH INFECTION OF HER HARDWARE/SEPTIC NONUNION ON (B)(6) 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/ 74MM/ XL25 THIS IS REPORT 4 OF 8 FOR COMPLAINT (B)(4).

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

  MAUDE report 15643859 ↗
• 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/ 74MM/ XL25. THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

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

  MAUDE report 13892266 ↗
• InjuryMar 18, 2022Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2022 THE PATIENT UNDERWENT REMOVAL OF 74MM & 68MM 5.0MM LOCKING SCREWS DUE TO BACK OUT. THE PROCEDURE AND PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR ONE (1) LOCKING SCREW FOR IM NAIL Ø 5MM/ 74MM/ XL25 THIS IS REPORT 1 OF 2 FOR COMPLAINT PC-(B)(4).

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

  MAUDE report 13805041 ↗
• MalfunctionMar 18, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6)2022, WHILE INSERTING A PROXIMAL INTERLOCKING SCREW, THE SCREW MISSED THE NAIL. IT IS BELIEVED THAT THE POST FROM THE FEMORAL COMPONENT CAUSED THE SCREW TO DIVERGE AND MISS THE HOLE. THE SCREW WAS REMOVED AND A NEW ONE REPLACED. ADDITIONALLY, THIS WAS A PLATE/NAIL CONSTRUCT AND A STAINLESS STEEL SCREW WAS PLACED THROUGH A PROXIMAL INTERLOCKING SCREW OF THE FEMORAL NAIL. THERE WAS FIVE (5) MINUTE SURGICAL DELAY. THE SURGERY WAS SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE (1) LOCKING SCREW. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13803960 ↗

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-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 A
• 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 A