NA 04.233.030SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982289117), received between Feb 11, 2022 and Feb 11, 2022 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 11, 2022Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT A HAD DISTAL FEMUR FRACTURE. THE NAIL WAS IMPLANTED APPROXIMATELY 14 WEEKS AGO, IN MID-SEPTEMBER. IT APPEARS THAT THE NAIL BROKE THROUGH THE MOST DISTAL OF THE PROXIMAL AP LOCKING SCREW HOLES. PATIENT UNDERWENT A REMOVAL OF THE HARDWARE AND RE-INSERTION OF NEW RFNA IN (B)(6) 2022. THIS REPORT INVOLVES ONE (1) RFNA / 10MM / 300MM 5 DEGREE BEND / STERILE. THIS IS REPORT 1 OF 1 FOR PC-(B)(4).

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

  MAUDE report 13513642 ↗

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