NA 04.233.138SRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982290670), received between Dec 19, 2022 and Jun 30, 2025 — classified as 5 injuries.

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJun 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2025 THE PATIENT PRESENTED WITH A NON-UNION OF A FEMORAL SHAFT FRACTURE INITIALLY FIXED WITH A DEPUY SYNTHES RFNA IMPLANT AT AN UNKNOWN DATE. THE RFNA NAIL WAS REMOVED AND REPLACED WITH A LARGER DEPUY SYNTHES RAFN NAIL TO TREAT THE FRACTURE NON-UNION. SURGICAL REVISION OF THE FRACTURE NON-UNION WAS REQUIRED.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 22365089 ↗
• InjuryFeb 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY ID: DEPUY - (B)(6) SUBJECT ID: (B)(6) IT WAS REPORTED THAT THE PATIENT SUFFERED FROM A NON UNION PROXIMAL FEMUR FRACTURE. THIS REPORT IS FOR ONE (1) RFNA/ 11MM/ 380MM/ STANDARD BEND/ STER THIS IS REPORT 1 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 18622234 ↗
• InjuryMay 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A REMOVAL OF RFNA AND REVISION TO REPLACEMENT RFNA/ VA CONDY CONSTRUCT DUE TO NON-UNION. THERE WAS NO SURGICAL DELAY. THIS REPORT IS FOR ONE (1) RFNA/ 11MM/ 380MM/ STANDARD BEND/ STER. THIS IS REPORT 1 OF 5 FOR COMPLAINT: (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 17030862 ↗
• InjuryMar 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NEW AE HAS BEEN REPORTED FOR SUBJECT (B)(6). ADVERSE EVENT TERM: LEFT THIGH HEMATOMA. SITE AWARENESS DATE: 06 FEB 2023. START DATE: 06 FEB 2023. TYPE OF EVENT: LOCAL/FRACTURE SITE. SIDE: LEFT. DEVICE: RFNA. SERIOUS: YES. RELATIONSHIP TO STUDY DEVICE: <<BLANK>>. RELATIONSHIP TO PRIMARY STUDY PROCEDURE: <<BLANK>>. THIS REPORT IS FOR A RFNA / 11MM / 380MM 5 DEGREE BEND / STERILE. THIS IS REPORT 2 OF 12 FOR (B)(4).

  Patient problems: Hematoma; Seroma

  MAUDE report 16462015 ↗
• InjuryDec 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WAS IMPLANTED WITH AN RFNA. THE PATIENT EXPERIENCED A NONUNION AND WILL NEED REVISION SURGERY. PATIENT#: 8. DIABETES: NO. OTHER THAT MAY AFFECT BONE HEALING (TEXT): ETOH ABUSE, OBESITY. DISTAL FEMUR FRACTURE: NO. NON-UNION: YES. MALUNION: NO. REVISION? (DID THE REOPERATION INCLUDE REMOVAL, ADJUSTMENT OR MODIFICATION OF A NAIL SYSTEM COMPONENT): NO. THIS REPORT IS FOR ONE (1) RFNA/ 11MM/ 380MM/ STANDARD BEND/ STER. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 16004748 ↗

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