NA 04.233.032SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982289124), received between Sep 10, 2021 and Apr 1, 2024 — classified as 3 injuries.

The most frequently reported specific device problem is “Use of Device Problem” (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.

• InjuryApr 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY ID: (B)(6). SUBJECT ID: (B)(6). IT WAS REPORTED THAT POST-OP WOUND INFECTION OCCURRED. THIS REPORT IS FOR ONE (1) RFNA/ 10MM/ 320MM/ STANDARD BEND/ STER. THIS IS REPORT 1 OF 7 FOR COMPLAINT (B)(4).

  Patient problems: Post Operative Wound Infection

  MAUDE report 19014936 ↗
• InjuryMar 21, 2024Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  THE INITIAL COMPLAINT WAS REVIEWED AND FOUND NOT REPORTABLE. REPORT IS A DUPLICATE. EVENT IS CAPTURED UNDER 8030965-2024-04304.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Infection

  MAUDE report 18949683 ↗
• InjurySep 10, 2021Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, A REDUCTION WAS ACHIEVED ON A FEMORAL SHAFT FRACTURE AND RETROGRADE FEMORAL NAILING SYSTEM (RFNA) DISPLACED FRACTURE BECAUSE THE RADIUS OF CURVATURE IS TOO GREAT. UPON PLACEMENT OF THE RFNA, THE REDUCTION WAS LOST, RESULTING IN AN APEX ANTERIOR DEFORMITY BECAUSE OF THE HIGH RADIUS OF CURVATURE OF THE NAIL, WHICH NEEDED TO BE REMOVED AND A RETROGRADE/ANTEGRADE FEMORAL NAIL (RAFN) NAIL WAS USED INSTEAD TO FIXATE THE FRACTURE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THIRTY(30) MINUTES SURGICAL DELAY. THIS REPORT IS FOR ONE (1) RFNA / 10MM / 320MM 5 DEGREE BEND / STERILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Physical Asymmetry

  MAUDE report 12456388 ↗

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-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
• 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