NA 04.233.220SRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982290816), received between Jan 23, 2024 and May 8, 2025 — classified as 5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMay 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED: TREATMENT/IMPACT: REVISION, INVOLVING ADJUSTMENT, MODIFICATION, REMOVAL OR REPLACEMENT OF ANY REGISTRY NAIL SYSTEM COMPONENTS, REOPERATION INVOLVING ADJUNCTIVE IMPLANTS, E.G. NON-REGISTRY COMPONENT SUCH AS PLATE, BLOCKING SCREW OR CABLE, TREATMENT OF NONUNION WITH COMPRESSION PLATING AND LOCAL BONE AUTOGRAFT, REMOVAL OF DEEP IMPLANTS (SCREWS IN PREVIOUSLY PLACED NAIL).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 21986904 ↗
• InjuryMar 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR NONUNION: DEVICE RELATED: NO. PROCEDURE RELATED: YES. DATE OF EVENT: 2024-12-05. DATE OF IMPLANT: (B)(6) 2023. DATE OF REVISION: NO INFORMATION PROVIDED. DEVICE LOCATION: NO INFORMATION PROVIDED. TREATMENT/IMPACT: NO INFORMATION PROVIDED. DEPUY SYNTHES PRODUCTS USED: CATALOG NUMBER: 04.233.220S. LOT NUMBER: NO INFORMATION PROVIDED. COMPONENT TYPE: RETROGRADE FEMORAL NAIL ADVANCED; 12MM; 200MM; 5° BEND - STERILE) RADE FEMORAL NAIL ADVANCED; 12MM; 200MM; 5° BEND - STERILE). DESCRIPTION: DPS - RETROGRADE FEMORAL NAIL ADVANCED. CATALOG NUMBER: 02.221.124. LOT NUMBER: NO INFORMATION PROVIDED. COMPONENT TYPE: VA-LCP PPFX PROXIMAL FEMUR PLATE 3.5/4.5/5.0; 11 HOLES; MM; STAINLESS STEEL. DESCRIPTION: DPS - VA-LCP PPFX PROXIMAL FEMUR PLATE 3.5/4.5/5.0.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 21586147 ↗
• InjuryMar 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT (B)(6). CLINICAL ADVERSE EVENTS RECEIVED FOR FIXATION FAILURE, DISPLACEMENT OF SCREWS DEVICE AND PROCEDURE (RELATEDNESS): YES DATE OF EVENT: 2025-02-13, DATE OF IMPLANT: (B)(6) 2023, DATE OF REVISION: NO INFORMATION PROVIDED, DEVICE LOCATION: NO INFORMATION PROVIDED, TREATMENT/IMPACT: NO INFORMATION PROVIDED.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 21562916 ↗
• InjuryJul 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT SURGICAL INTERVENTION AT THE FRACTURE SITE AND RECEIVED A RETROGRADE FEMORAL NAIL 12MM: LENGTH 200MM. THE PATIENT EXPERIENCED HYPERTROPHIC NONUNION RESULTING IN REVISION WHICH WAS PERFORMED ON (B)(6), 2024. THIS REPORT INVOLVES ONE (1) RFNA / 12MM / 200MM STANDARD BEND / STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 19752748 ↗
• InjuryJan 23, 2024Migration; Migration

  SEVERAL ALLEGATIONS WERE REPORTED IN POST MARKET STUDY ID: DEPUY - (B)(6); SUBJECT ID: (B)(6) . IT WAS REPORTED A RETROGRADE FEMORAL NAIL ADVANCED (RFNA) MIGRATION OCCURRED ON AN UNKNOWN DATE. DATE OF INITIAL INJURY WAS (B)(6) 2023 AND DUE TO A HIGH TRAUMA EVENT RESULTING IN A RIGHT FEMUR 32C MULTI FRAGMENT SHAFT FRACTURE AND PERIPROSTHETIC FRACTURE. INITIAL SURGERY WAS COMPLETED ON (B)(6) 2023. A NAIL AND 3 SCREWS WERE IMPLANTED. ON (B)(6) 2024 IT WAS NOTED IN THE STUDY THAT THE NAIL HAD MIGRATED AND REVISION SURGERY WAS REQUIRED. THIS REPORT IS FOR ONE RFNA/ 12MM/ 200MM/ STANDARD BEND/ STER NAIL FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18563905 ↗

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