NA 04.233.238SRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982290885), received between Aug 31, 2021 and Jun 8, 2024 — classified as 4 injuries.

The most frequently reported specific device problem is “Migration” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJun 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS STUDY ID: DEPUY - DST202103. SUBJECT ID: 01438-042 EXPERIENCED A CLINICAL ADVERSE EVENT. RECEIVED FOR R THIGH WOUND DEHISCENCE OF THE LOCAL/FRACTURE SITE THE PRINCIPLE INVESTIGATOR HAS NOT PROVIDED RELATIONSHIP INFORMATION. HOWEVER THE: DATE OF EVENT: 05-MAY-2024. DATE OF IMPLANT: (B)(6) 2024. DATE OF REVISION: N/A. DEVICE LOCATION: RIGHT DISTAL FEMUR. THE SURGICAL INTERVENTION WAS PERFORMED ON (B)(6) 2024. PATIENT DISCHARGED FROM HOSPITAL (B)(6) 2024. TREATMENT: SURGICAL INTERVENTION OF IRRIGATION AND DEBRIDEMENT. DEPUY SYNTHES PRODUCTS USED: RFNA AND 5 LOCKING SCREWS CATALOG NUMBER: 04.233.238S. LOT NUMBER: N/A. COMPONENT TYPE: (RETROGRADE FEMORAL NAIL ADVANCED: 12MM: LENGTH 380MM). DESCRIPTION: THE EVENT IS RATED AS SEVERE AND SERIOUS DUE TO IN-PATIENT HOSPITALIZATION OR PROLONGATION OF EXISTING HOSPITALIZATION (ADMITTED (B)(6) -2024), AND RESULTED IN MEDICAL OR SURGICAL INTERVENTION AT THE FRACTURE SITE TO PREVENT LIFE-THREATENING ILLNESS OR INJURY OR PERMANENT IMPAIRMENT TO A BODY STRUCTURE OR A BODY FUNCTION. THIS REPORT IS FOR ONE (1) RFNA/ 12MM/ 380MM/ STANDARD BEND/ STER. THIS IS REPORT 1 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: Wound Dehiscence

  MAUDE report 19493069 ↗
• InjuryMay 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD ADVERSE EVENT OF PSEUDOMONAS. PATIENT WAS IMPLANTED WITH RFNA. THIS REPORT IS FOR A RFNA / 12MM / 380MM 5 DEGREE BEND / STERILE. THIS IS REPORT 7 OF 10 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture; Post Operative Wound Infection

  MAUDE report 16855789 ↗
• InjuryJul 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD ADVERSE EVENT OF PSEUDOMONAS. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) RFNA / 12 / 380 5 DEG BEND / STERILE. THIS IS REPORT 1 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: Post Operative Wound Infection

  MAUDE report 14939903 ↗
• InjuryAug 31, 2021Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2021, A REVISION SURGERY WAS PERFORMED TO TIGHTEN/REINSERT DISTAL SCREWS THAT BACKED OUT OF THE RFNA IMPLANT POSTOPERATIVELY. NON UNION DISTAL FEMUR FRACTURE ALSO OCCURED. THE DISTAL SCREWS OF THE RFNA NAIL BACKED OUT POST OPERATIVELY DURING THE HEALING PROCESS AND PRIOR TO ANY WEIGHT BEARING. ANOTHER PROCEDURE WAS NEEDED TO REINSERT THE DISTAL SCREWS OF THE RFNA. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) RFNA / 12 / 380 5 DEG BEND / STERILE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Malunion of Bone

  MAUDE report 12394246 ↗

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