NA 04.045.086Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886982293381), received between Feb 9, 2022 and May 26, 2025 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Migration” (5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMay 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH A RETROGRADE FEMORAL NAIL ADVANCED (RFNA) ON (B)(6) 2025. AN OPEN REDUCTION AND RETROGRADE INTRAMEDULLARY NAILING OF THE LEFT FEMUR SURGERY OCCURRED ON (B)(6) 2025. POST-OPERATIVELY X-RAYS SHOWED SIGNIFICANT BACK-OUT AND THE SCREW WAS PROMINENT. THE PATIENT HAD LIMITED FRACTURE HEALING AT THAT POINT, SO THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2025, FOR SCREW EXCHANGE AND PLACEMENT OF A LOCKING NUT THAT THREADS ONTO THE SCREW. LATER IT WAS DISCOVERED THAT THE LOCKING NUT AND SCREW WERE DISENGAGED, AND THE SCREW WAS PARTIALLY BACKED OUT. ON (B)(6) 2025, ANOTHER SURGERY WAS PERFORMED FOR LEFT FEMUR REMOVAL OF HARDWARE, REVISION OF IM NAILING. POST-OPERATIVE FOLLOW-UP INDICATE THAT THE PATIENT APPEARS STABLE, AND IMAGING SHOWED NO LOOSENING OR FAILURES AT THE PRESENT TIME; THE FRACTURE ALIGNMENT REMAINS STABLE. THIS REPORT CAPTURES THE THIRD REMOVAL EVENT THAT OCCURRED ON (B)(6) 2025. THE FIRST REMOVAL EVENT THAT OCCURRED ON (B)(6) 2025, IS CAPTURED ON RELATED COMPLAINT (B)(4). THE SECOND REMOVAL EVENT THAT OCCURRED ON (B)(6) 2025, IS CAPTURED ON RELATED COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 22084173 ↗
• MalfunctionMay 3, 2023Migration; Migration

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DISTAL SCREWS BACKED OUT OF THE ADVANCED RETROGRADE NAIL. IT WAS UNKNOWN IF THERE WAS A PATIENT OUTCOME. CONCOMITANT PRODUCT: UNK - NAILS: RFNA(PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1). THIS REPORT IS FOR ONE (1) LOCKING SCREW FOR IM NAIL 5/ 86/ XL25. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16860226 ↗
• InjuryApr 21, 2023Migration; Migration

  IT WAS REPORTED THAT ON (B)(6)2023, TWO OF THE FOUR DISTAL LOCKING SCREWS IN A RETROGRADE FEMORAL NAILING SYSTEM(RFNA) NAIL STARTED TO BACK OUT. ONE OF THE SCREW WAS TRYING THE SKIN. THIS REPORT IS FOR ONE (1) LOCKING SCREW FOR IM NAIL Ø 5MM/ 86MM/ XL25. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 16782512 ↗
• InjuryApr 21, 2023Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2023, TWO OF THE FOUR DISTAL LOCKING SCREWS IN A RETROGRADE FEMORAL NAILING SYSTEM(RFNA) NAIL STARTED TO BACK OUT. ONE OF THE SCREW WAS TRYING THE SKIN. THIS REPORT IS FOR ONE (1) LOCKING SCREW FOR IM NAIL Ø 5MM/ 86MM/ XL25. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 16782511 ↗
• InjuryMar 19, 2022Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDER A HARDWARE REMOVAL PROCEDURE TO REMOVE THE LATERAL OBLIQUE LOCKING SCREW OF THE RETROGRADE FEMORAL NAIL ADVANCED (RFNA) BECAUSE IT HAD BACKED OUT. THIS REPORT IS FOR A LOCKING SCREW. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 13824511 ↗
• InjuryFeb 9, 2022Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2021 THE PATIENT UNDERWENT AN INITIAL SURGERY WHERE AN 85MM ANS 5.0MM LOCKING SCREW WAS INSERTED UNDER POWER INTO THE DISTAL MOST SCREW HOLE OF A 12MM X 360MM 5 DEGREE BEND RETROGRADE FEMORAL NAIL ADVANCED IN A LATERAL-TO-MEDIAL FASHION. POSTOPERATIVELY ON (B)(6) 2021 IT WAS DISCOVERED THAT THE SCREW DESCRIBED ABOVE HAD BACKED OUT LATERALLY FROM THE NAIL SIGNIFICANTLY. REVISION SURGERY WAS REQUIRED DUE TO A NON-UNION OF THE FEMUR AND WAS PERFORMED ON (B)(6) 2022 WHEN THE SCREW WAS EXPLANTED AND MORE BLOCKING SCREWS WERE INSERTED. THE PATIENT WILL CONTINUE TO BE FOLLOWED BY THE SURGEONS CLINIC. PATIENT STATUS IS UNKNOWN. THIS REPORT IS FOR ONE (1) LOCKING SCREW FOR IM NAIL Ø 5MM/ 86MM/ XL25 THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 13502115 ↗

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