NA 04.233.038SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982289155), received between Mar 8, 2022 and Jul 27, 2023 — classified as 2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS FOR A POST MARKET STUDY AND CAPTURES THE RADIOLOGIC ASSESSMENTS AT 6 WEEKS AND 3 MONTHS POST-OP, WHICH SHOW THAT UNION HAS NOT BEEN ACHIEVED. THIS REPORT INVOLVES ONE (1)RFNA/ 10MM/ 380MM/ STANDARD BEND/ STER. THIS IS REPORT 1 OF 10 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 17407643 ↗
• InjuryMar 8, 2022Break; Break

  IT WAS REPORTED ON (B)(6) 2022, THE PATIENT UNDERWENT REMOVAL OF A BROKEN RETROGRADE FEMORAL NAIL ADVANCED (RFNA). IT WAS REMOVED SUCCESSFULLY. THE PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES ONE (1) DEVICE RFNA / 10 / 380 5 DEG BEND / STERILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

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

  MAUDE report 13693109 ↗

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