NA 04.233.040SRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10886982289162), received between Dec 6, 2022 and Oct 22, 2024 — classified as 7 injuries.

The most frequently reported specific device problem is “Break” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryOct 22, 2024Break; Break

  SUBJECT ID: (B)(6). STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR DEVICE BREAKAGE DEVICE AND PROCEDURE(RELATEDNESS): DEVICE RELATED: CAUSAL RELATIONSHIP PROCEDURE RELATED: NOT RELATED DATE OF EVENT: 19/09/2024 DATE OF IMPLANT: NO INFORMATION PROVIDED DATE OF REVISION: (B)(6) 2024. DEVICE LOCATION: LEFT TREATMENT/IMPACT: SURGICAL INTERVENTION AT THE FRACTURE SITE: DEPUY SYNTHES PRODUCTS USED: CATALOG ID: 04.233.040S. LOT ID: 4801P12. COMPONENT TYPE: NO INFORMATION PROVIDED DESCRIPTION: RETROGRADE FEMORAL NAIL ADVANCED: 10MM: LENGTH 400MM.

  Patient problems: Insufficient Information

  MAUDE report 20506653 ↗
• InjuryOct 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED: CLINICAL ADVERSE EVENT RECEIVED FOR DEVICE BREAKAGE (SCREW BREAKAGE AND SCREW BACKOUT) DEVICE RELATED: CAUSAL RELATIONSHIP PROCEDURE RELATED: NOT RELATED.

  Patient problems: Insufficient Information

  MAUDE report 20396397 ↗
• InjuryNov 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY ID: DEPUY - DST202103, SUBJECT ID: (B)(6). IT WAS REPORTED THAT LEFT TIBIAL FRACTURE OCCURRED. TYPE OF EVENT: LOCAL/FRACTURE SITE , DEVICE: RFNA . THIS REPORT IS FOR ONE (1) RFNA/ 10MM/ 400MM/ STANDARD BEND/ STER THIS IS REPORT 1 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 18064663 ↗
• InjuryNov 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). TYPE OF EVENT: LOCAL/FRACTURE SITE. DEVICE: RFNA. OUTCOME: RECOVERING/RESOLVING. THIS REPORT IS FOR AN RFNA / 10MM / 400MM STANDARD BEND / STERILE. THIS IS REPORT 1 OF 9 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18049283 ↗
• InjuryMay 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ADVERSE EVENT WAS REPORTED FOR SUBJECT (B)(6) IN A CLINICAL STUDY AS FOLLOWS: THE PATIENT SUSTAINED A LOW ENERGY TRAUMA INJURY RESULTING IN A DISTAL FEMORAL FRACTURE ON (B)(6) 2022. AN RFNA NAIL WAS IMPLANTED TO THE LEFT FEMUR ON (B)(6) 2022. SIX LOCKING SCREWS WERE USED FOR FIXATION. ON (B)(6) 2023, NONUNION WAS CONFIRMED, RESULTING IN IN-PATIENT HOSPITALIZATION AND SURGICAL INTERVENTION. THE NAIL WAS REMOVED, AND A RESECTION LEFT TOTAL FEMUR + LEFT TOTAL FEMUR ENDOPROSTHESIS WITH TOTAL HIP AND KNEE REPLACEMENT WERE PERFORMED. THE OUTCOME IS RECOVERING/RESOLVING. THIS REPORT INVOLVES ONE RFNA / 10MM / 400MM 5 DEGREE BEND / STERILE. THIS IS REPORT 1 OF 8 FOR (B)(4).

  Patient problems: Bone Fracture(s); Nonunion/Delayed-union Bone Fracture

  MAUDE report 17009731 ↗
• InjuryFeb 3, 2023Adverse 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 REVISION FEMORAL NAILING FOR NON-UNION AND MAL-UNION. THE DEVICES WERE REMOVED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE RFNA / 10MM / 400MM 5 DEGREE BEND / STERILE. THIS IS REPORT 1 OF 6 FOR (B)(4).

  Patient problems: Malunion of Bone; Nonunion/Delayed-union Bone Fracture

  MAUDE report 16296013 ↗
• InjuryDec 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE AE HAS BEEN REPORTED FOR SUBJECT (B)(6) FOR THE (B)(4) STUDY: AE TERM: LEFT PROXIMAL PERIPROSTHETIC FEMUR FRACTURE. SITE AWARENESS DATE: 10 NOVEMBER 2022. START DATE: (B)(4) 2022. SERIOUS: SEVERE. RELATIONSHIP TO STUDY DEVICE: BLANK. RELATIONSHIP TO STUDY PROCEDURE: BLANK. THIS REPORT IS FOR ONE (1)RFNA/ 10MM/ 400MM/ STANDARD BEND/ STER. THIS IS REPORT 8 OF 8 FOR COMPLAINT (B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 15926058 ↗

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