NA 04.233.442SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982291189), received between Jul 14, 2022 and May 14, 2024 — classified as 2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMay 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT: EVENT DESCRIPTION: STUDY ID: (B)(6) SUBJECT ID: (B)(6) CLINICAL ADVERSE EVENT RECEIVED FOR DVT EVENT IS PROBABLY RELATED TO THE DEVICE AND NOT RELATED TO THE DATE OF EVENT: 04-APR-2024 DATE OF IMPLANT: (B)(6) 2024 DEVICE LOCATION: LEFT DISTAL FEMUR TREATMENT: ORAL/TOPICAL MEDICATION DEPUY SYNTHES PRODUCTS USED (LOT NUMBERS NOT PROVIDED): QTY 1 RFNA (04.233.442S (RETROGRADE FEMORAL NAIL ADVANCED: 14MM: LENGTH 420MM) QTY 1 WASHER (02.233.101S (LOCKING ATTACHMENT WASHER: LEFT)) QTY 1 END CAP (04.233.000S (END CAP FOR RFNA: 0 MM)) QTY 5 LOCKING SCREWS (PRODUCT NUMBER NOT PROVIDED) OUTCOME: RECOVERING/RESOLVING STUDY ID: (B)(6). SUBJECT ID: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR DVT: EVENT IS PROBABLY RELATED TO THE DEVICE AND NOT RELATED TO PROCEDURE. DATE OF EVENT: 04-APR-2024. DATE OF IMPLANT: (B)(6) 2024. DEVICE LOCATION: LEFT DISTAL FEMUR. TREATMENT: ORAL/TOPICAL MEDICATION. DEPUY SYNTHES PRODUCTS USED (LOT NUMBERS NOT PROVIDED): QTY 1 RFNA (04.233.442S (RETROGRADE FEMORAL NAIL ADVANCED: 14MM: LENGTH 420MM). QTY 1 WASHER (02.233.101S (LOCKING ATTACHMENT WASHER: LEFT)). QTY 1 END CAP (04.233.000S (END CAP FOR RFNA: 0 MM)). QTY 5 LOCKING SCREWS (PRODUCT NUM

  Patient problems: Thrombosis/Thrombus

  MAUDE report 19315390 ↗
• InjuryJul 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, DURING POST-OP EVENT BILATERAL REVISION OF FEMUR FIXATION DONE DUE TO NON-UNION AND MAL REDUCTION. THERE WAS A PATIENT CONSEQUENCE. ON THE RIGHT SIDE THERE WAS THE REMOVAL OF FOUR (4) SCREWS FROM A PLATE, COMPRESSION APPLICATION AND RE-INSERTION OF NEW SCREWS INTO EXISTING PLATE WAS DONE. ON THE LEFT SIDE THERE WAS REMOVAL OF RETROGRADE FEMORAL NAIL WITH THREE (3) SCREWS AND NEW IMPLANTATION OF NAIL WITH COMPRESSION PLATING WAS DONE. ONE SCREW WAS BROKEN. THIS REPORT IS FOR ONE (1) RFNA / 14 / 420 5 DEG BEND / STERILE. THIS IS REPORT 1 OF 4 FOR COMPLAINT.

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

  MAUDE report 15015290 ↗

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