NA 04.233.930SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982288554), received between Aug 4, 2022 and Sep 20, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Break” (2 reports).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjurySep 20, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT REVISION OF THE RIGHT FEMUR DUE TO A BROKEN RETROGRADE FEMORAL NAIL. HARDWARE REMOVAL AND REVISION WAS PERFORMED. DUE TO THE NAIL BREAKAGE, THE PATIENT EXPERIENCED MAL-REDUCTION AND NON-UNION. NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: Nonunion/Delayed-union Bone Fracture; Physical Asymmetry

  MAUDE report 20267177 ↗
• InjuryAug 4, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2022, A REVISION PROCEDURE WAS PERFORMED ON A RETROGRADE FEMORAL NAIL AFTER THE NAIL HAD BROKEN THROUGH A SCREW HOLE PROXIMALLY THAT WAS LEFT EMPTY DURING IMPLANTATION. IT APPEARED THAT THE SCREW HOLE WAS RIGHT ALONG THE FRACTURE LINE. THE SURGEON REMOVED THE BROKEN NAIL AND THEN PLACED A RETROGRADE NAIL OF ANOTHER BRAND THAT WAS OF LONGER LENGTH. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A RFNA / 9MM / 300MM 5 DEGREE BEND / STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 15168838 ↗

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