NA 04.233.000SRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886982288318), received between Jan 27, 2023 and Jul 15, 2025 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (2 reports).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 15, 2025Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THE DEVICE WAS NOT ABLE TO SCREW IN PLACE THE END CAP OF RFNA NAIL. ANOTHER DEVICE WAS USED AND IT WENT SMOOTHLY. IT LOOKED LIKE THE END CP DID NOT ENGAGE AND COULD NOT BE SCREWED ON ALL THE WAY IN. UNKNOWN SURGICAL DELAY. UNKNOWN HOW PROCEDURE WAS COMPLETED. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22507078 ↗
• MalfunctionJun 12, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2024 TWO THREADS WERE DAMAGED. THERE WAS NO OPERATION INVOLVED, NO PATIENT CONSEQUENCES AND NO PATIENT INVOLVED. NO OTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE (1) END CAP FOR RFNA / 0MM STERILE THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19525144 ↗
• MalfunctionJun 12, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON MAY 17, 2024 TWO THREADS WERE DAMAGED. THERE WAS NO OPERATION INVOLVED, NO PATIENT CONSEQUENCES AND NO PATIENT INVOLVED. NO OTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE (1) END CAP FOR RFNA / 0MM STERILE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19525108 ↗
• 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: DEPUY - DST202103 SUBJECT ID: 00720-007 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 (B)(4) RFNA (04.233.442S (RETROGRADE FEMORAL NAIL ADVANCED: 14MM: LENGTH 420MM) QTY (B)(4) 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: DEPUY - DST202103 SUBJECT ID: 00720-007 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 (B)(6) RFNA (04.233.442S (RETROGRADE FEMORAL NAIL ADVANCED: 14MM: LENGTH 420MM) QTY (B)(6) WASHER (02.233.101S (LOCKING ATTACHMENT WASHER: LEFT)) QTY (B)(6) END CAP (04.233.000S (END CAP FOR RFN

  Patient problems: Thrombosis/Thrombus

  MAUDE report 19315406 ↗
• InjuryNov 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY ID: DEPUY (B)(6). SUBJECT ID: (B)(6). ADVERSE EVENT TERM: SCREW BACK OUT ASSOCIATED WITH INCREASED DISCOMFORT AND SWELLING IS THIS A WORSENING OF AN EXISTING EVENT? YES. CREATION DATE: 24-10-2023. SITE AWARENESS DATE: 23-10-2023. TYPE OF EVENT: LOCAL/FRACTURE SITE. DEVICE: RFNA. THIS REPORT IS FOR AN END CAP FOR RFNA / 0MM STERILE. THIS IS REPORT 3 OF 5 FOR (B)(4).

  Patient problems: Discomfort; Nonunion/Delayed-union Bone Fracture; Pain; Swelling/ Edema

  MAUDE report 18132140 ↗
• InjuryJan 27, 2023Break; Break

  THE FOLLOWING ADVERSE EVENT WAS REPORTED FOR SUBJECT (B)(6) FOR THE (B)(4) STUDY: IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY TO IMPLANT LEFT SIDE RFNA ON (B)(6) 2022. ON (B)(6) 2023, IT WAS NOTED THAT THE PATIENT SUFFERED HARDWARE BREAKAGE, WHICH WILL REQUIRE REVISION SURGERY. AS OF (B)(6) 2023, REVISION HAD NOT BEEN SCHEDULED YET. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE END CAP FOR RFNA / 0MM STERILE. THIS IS REPORT 2 OF 8 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 16252841 ↗

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