NA 04.233.136SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982290663), received between Sep 18, 2024 and Jul 10, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Break” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K201346, K233696); 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJul 10, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT PRESENTED TO THE ER WITH PROXIMAL FEMORAL PAIN. THE PATIENT PREVIOUSLY HAD AN OSTEOSARCOMA REMOVED FROM THEIR LEFT MIDSHAFT FEMUR AND A LARGE SEGMENT WAS REPLACED WITH AN ALLOGRAFT FEMUR AND FIXATED WITH A DEPUY SYNTHES RFNA. AT SOMETIME POSTOPERATIVELY, THE PROXIMAL END OF THE RFNA HAD BROKEN THROUGH ONE OF THE EMPTY SCREW HOLES. THE NAIL WAS REMOVED AND REPLACED WITH A 12X360MM STANDARD BEND RFNA AND A 18 HOLE VA-LCP CURVED CONDYLAR PLATE.

  Patient problems: Pain

  MAUDE report 22467630 ↗
• 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 22084136 ↗
• InjurySep 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED AS FOLLOWS: RELATIONSHIP TO PRIMARY STUDY PROCEDURE: PROBABLE RELATIONSHIP TO STUDY DEVICE: POSSIBLE TREATMENT: SURGICAL INTERVENTION AT THE FRACTURE SITE RESULTED IN MEDICAL OR SURGICAL INTERVENTION TO PREVENT LIFE-THREATENING ILLNESS OR INJURY OR PERMANENT IMPAIRMENT TO A BODY STRUCTURE OR A BODY FUNCTION.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 20250751 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K201346, K233696. 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