NA 02.233.101SRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10886982289322), received between Dec 6, 2022 and Oct 11, 2024 — classified as 7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryOct 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT HAD A DIAGNOSIS BECAUSE OF NON-UNION, MAL-UNION AND ALSO HAD HARDWARE REMOVAL. NO OTHER INFORMATION WAS PROVIDED AT THIS TIME.

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

  MAUDE report 20429204 ↗
• 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)(4) RFNA (04.233.442S (RETROGRADE FEMORAL NAIL ADVANCED: 14MM: LENGTH 420MM) QTY (B)(4) WASHER (02.233.101S (LOCKING ATTACHMENT WASHER: LEFT)) QTY (B)(4) END CAP (04.233.000S (END CAP FOR RFN

  Patient problems: Thrombosis/Thrombus

  MAUDE report 19315397 ↗
• InjuryApr 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A REVISION SURGERY OCCURRED (B)(6) 2024 DUE TO A MALUNION/NONUNION. SURGEON REMOVED ALL IMPLANTS THAT WERE CURRENTLY IN PATIENT. RIA WAS USED TO COLLECT BONE GRAFT AND CLEAN OUT THE SURGICAL SITE. SURGEON INSERTED NEW IMPLANTS AFTER RESTORING ALIGNMENT AND LENGTH. ORIGINAL IMPLANT DATE UNKNOWN. IT IS NOT KNOWN HOW LONG THE DEVICES HAVE BEEN IMPLANTED FOR. THIS REPORT IS FOR ONE LCKNG ATTACH WASHER RFNA / 5 DEG/ LT/ S FOR (B)(4).

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

  MAUDE report 19043031 ↗
• 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 LOCKING ATTACHMENT WASHER F/ RFNA / 5 DEG/ LEFT/ STER. THIS IS REPORT 2 OF 8 FOR (B)(4).

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

  MAUDE report 17009732 ↗
• 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) 2022, PATIENT UNDERWENT OPEN REDUCTION INTERNAL FIXATION (ORIF) PROCEDURE WITH LEFT RETROGRADE FEMORAL NAIL ADVANCED (RFNA) TO TREAT DISTAL FEMUR FRACTURE. POSTOPERATIVELY PATIENT EXPERIENCED CLOSED FRACTURE OF LEFT FEMUR WITH NONUNION, PAIN, WOUND INFECTION WHICH RESULTED IN MEDICAL OR SURGICAL INTERVENTION. PATIENT OUTCOME IS REPORTED AS RECOVERED/RESOLVED. POST MARKET STUDIES SUBJECT ID (B)(4). THIS REPORT IS FOR ONE (1) LOCKING ATTACHMENT WASHER F/ RFNA / 5 DEG/ LEFT/ STER. THIS IS REPORT 2 OF 8 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture; Pain; Post Operative Wound Infection

  MAUDE report 16987448 ↗
• InjuryApr 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) THAT THE PATIENT EXPERIENCED PAIN, NONUNION, AND WOUND INFECTION. THE WOUND INFECTION REQUIRED SURGICAL INTERVENTION. THE ADVERSE EVENT HAS BEEN REPORTED FOR SUBJECT (B)(6) FOR THE DST202103 STUDY: THE ADVERSE EVENT TERM: ACUTE LEFT ANKLE PAIN & ACUTE KNEE PAIN. SITE AWARENESS DATE: (B)(6) 2023 START DATE: (B)(6) 2023 TYPE OF EVENT: LOCAL/FRACTURE SITE DEVICE: RFNA THIS REPORT IS FOR ONE (1) LCKNG ATTACH WASHER RFNA / 5 DEG/ LT/ S THIS IS REPORT 9 OF 9 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture; Pain; Post Operative Wound Infection

  MAUDE report 16791717 ↗
• 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 00164-035 FOR THE DST202103 STUDY: AE TERM: LEFT PROXIMAL PERIPROSTHETIC FEMUR FRACTURE. SITE AWARENESS DATE: (B)(6) 2022. START DATE: (B)(6) 2022. SERIOUS: SEVERE. RELATIONSHIP TO STUDY DEVICE: BLANK. RELATIONSHIP TO STUDY PROCEDURE: BLANK. THIS REPORT IS FOR ONE (1) LCKNG ATTACH WASHER RFNA / 5 DEG/ LT/ S. THIS IS REPORT 1 OF 8 FOR COMPLAINT (B)(4).

  Patient problems: Limb Fracture

  MAUDE report 15925644 ↗

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