NA 04.233.142SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982290694), received between Oct 13, 2023 and Apr 22, 2025 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryApr 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY ID: (B)(6) SUBJECT ID: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR KNEE PAIN DEVICE AND PROCEDURE (RELATEDNESS) DEVICE RELATED: NO INFORMATION PROVIDED PROCEDURE RELATED: NO INFORMATION PROVIDED DATE OF EVENT: 12 FEB 2025. DATE OF IMPLANT: (B)(6) 2024. DATE OF REVISION: NO INFORMATION PROVIDED. DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: HOSPITALIZATION AND SURGICAL INTERVENTION AT THE FRACTURE SITE. DEPUY SYNTHES PRODUCTS USED: CATALOG NUMBER: 04.233.142S LOT NUMBER: 3412P36 COMPONENT TYPE: RFNA DESCRIPTION: RETROGRADE FEMORAL NAIL ADVANCED: 11MM: LENGTH 420MM. CATALOG NUMBER: 02.233.100S LOT NUMBER: NO INFORMATION PROVIDED COMPONENT TYPE: LOCKING ATTACHMENT WASHER: RIGHT DESCRIPTION: NO INFORMATION PROVIDED. CATALOG NUMBER: NO INFORMATION PROVIDED LOT NUMBER: NO INFORMATION PROVIDED COMPONENT TYPE: WERE LOCKING SCREWS DESCRIPTION: NO INFORMATION PROVIDED. CATALOG NUMBER: NO INFORMATION PROVIDED LOT NUMBER: NO INFORMATION PROVIDED COMPONENT TYPE: WERE LOCKING SCREWS DESCRIPTION: NO INFORMATION PROVIDED. CATALOG NUMBER: NO INFORMATION PROVIDED LOT NUMBER: NO INFORMATION PROVIDED COMPONENT TYPE: WERE LOCKING SCREWS DESCRIPTION: NO INFORMATION PROVIDED. CATALOG NUMBER: NO INFORMA

  Patient problems: Pain

  MAUDE report 21883232 ↗
• InjuryMay 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE INVOLVED THE REMOVAL OF THE VA CONDYLAR PLATE AND RETROGRADE FEMORAL NAILING SYSTEM (RFNA) DUE TO NON-UNION OF THE FEMUR. THIS REPORT IS FOR ONE (1) RFNA / 11MM / 420MM STANDARD BEND / STERILE. THIS IS REPORT 4 OF 10 FOR COMPLAINT (B)(4) .

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 19354968 ↗
• InjuryOct 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON AN UNKNOWN DATE, THAT THEY HAD A PATIENT COME IN WITH A HYPERTROPHIC NON-UNION WITH A RETROGRADE FEMORAL NAIL ADVANCED PUT IN ABOUT 6 MONTHS AGO. THE CONSTRUCT INCLUDED TWO A TO P SCREWS PROXIMALLY AND TWO LATERAL TO MEDIAL SCREWS DISTALLY. THE TWO SCREWS DISTALLY WERE IN FACT BROKEN AT THE NAIL. THE LATERAL FRAGMENTS WERE REMOVED USING THE T25XL SCREW DRIVER. THE MEDIAL PIECES WERE PUSHED THROUGH THE MEDIAL ASPECT OF THE FEMUR. NO PIECES WERE LEFT IN THE PATIENT AND THE PROCEDURE WAS COMPLETED ONCE THE NAIL AND SCREWS WERE REMOVED. THE NAIL AND SCREWS ARE NOT AVAILABLE FOR RETURN. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A SURGICAL DELAY OF 15 MINUTES. THERE WERE NO PATIENT OUTCOMES REPORTED. THIS REPORT IS FOR ONE (1) RFNA/ 11MM/ 420MM/ STANDARD BEND/ STER. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 17930701 ↗

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