NA 02.233.100SRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982289223), received between May 23, 2023 and Mar 6, 2026 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMar 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2026 THAT THE PATIENT WAS REVISED AND HARDWARE WERE REMOVED DUE TO NON-UNION AND MAL-UNION

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

  MAUDE report 24531333 ↗
• 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

  Patient problems: Pain

  MAUDE report 21883263 ↗
• InjuryAug 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6) . IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY TO IMPLANT THE DEVICES ON (B)(6) 2024. POSTOPERATIVELY, THE PATIENT EXPERIENCED WOUND DEHISCENCE, WHICH REQUIRED SURGICAL INTERVENTION AT THE FRACTURE SITE. THIS REPORT INVOLVES ONE LOCKING ATTACHMENT WASHER F/ RFNA / 5 DEG/ RIGHT/ STER. THIS IS REPORT 10 OF 10 FOR (B)(4). THIS REPORT IS RELATED TO (B)(4) WHICH CAPTURES ADDITIONAL IMPLANTS RELATED TO THE EVENT.

  Patient problems: Wound Dehiscence

  MAUDE report 19948985 ↗
• InjuryMay 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2023, PATIENT UNDERWENT OPEN REDUCTION INTERNAL FIXATION (ORIF) PROCEDURE WITH LEFT RETROGRADE FEMORAL NAIL ADVANCED (RFNA) TO TREAT FEMORAL SHAFT FRACTURE. POSTOPERATIVELY PATIENT EXPERIENCED WOUND DEHISCENCE. PATIENT OUTCOME IS REPORTED AS RECOVERED/RESOLVED. POST MARKET STUDIES SUBJECT ID - 00256-024. THIS REPORT IS FOR ONE (1) LOCKING ATTACHMENT WASHER F/ RFNA / 5 DEG/ RIGHT/ STER. THIS IS REPORT 8 OF 13 FOR COMPLAINT (B)(4).

  Patient problems: Wound Dehiscence

  MAUDE report 16989092 ↗

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