NA 04.233.140SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982290687), received between Apr 14, 2022 and Aug 18, 2025 — 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.

• InjuryAug 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6) STUDY NO: (B)(4). CLINICAL ADVERSE EVENT RECEIVED FOR LEFT FEMORAL NECK FRACTURE - PERI-IMPLANT DEVICE AND PROCEDURE(RELATEDNESS). DEVICE RELATED: POSSIBLE, PROCEDURE RELATED: NOT RELATED. DATE OF EVENT: 05 JUN 2025. DATE OF IMPLANT: (B)(6) 2024. DATE OF REVISION: NO INFORMATION PROVIDED. DEVICE LOCATION: LEFT. TREATMENT/IMPACT: REQUIRED IN-PATIENT HOSPITALIZATION OR PROLONGATION OF EXISTING HOSPITALIZATION, RESULTED IN MEDICAL OR SURGICAL INTERVENTION TO PREVENT LIFE-THREATENING ILLNESS OR INJURY OR PERMANENT IMPAIRMENT TO A BODY STRUCTURE OR A BODY FUNCTION, SURGICAL INTERVENTION NOT AT THE FRACTURE SITE (DEEP HARDWARE REMOVAL AND OPEN REDUCTION INTERNAL FIXATION FEMORAL NECK FRACTURE: BOTH 4.5 CORTICAL SCREWS WERE REMOVED. THEY WERE OBVIOUSLY BENT. REPLACED THEM WITH 6.5 MM CANCELLOUS SCREWS. GUIDEWIRES FOR PLANNED PLACEMENT OF TWO 6.5 CANNULATED SCREWS. CHECKED THE GUIDEWIRES ON MULTIPLE FLUOROSCOPIC VIEWS AND FOUND TO BE IN GOOD POSITION ALIGNMENT. WE USED A DRILL TO DRILL THE LATERAL CORTEX. WE THEN ADVANCED BOTH SCREWS AFTER MEASURING. SCREWS HAD GOOD TO FINGER BITE. REMOVE THE GUIDEWIRES) DEPUY SYNTHES PRODUCTS USED: CATALOG NUMBER: 04.233.140S LOT NUMBER

  Patient problems: Bone Fracture(s)

  MAUDE report 22825991 ↗
• InjuryApr 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, THE PATIENT CAME TO OPERATING ROOM FOR REMOVAL OF RFNA DUE TO INFECTION. THE SURGEON VOICED THAT AFTER NAIL WAS ORIGINALLY INSERTED PATIENT HAD RECEIVED HEPARIN FOR A SIGNIFICANT PE AND DEVELOPED A LARGE HEMATOMA AT SURGICAL SITE WHICH ULTIMATELY LEAD TO THE WOUND BREAKING DOWN. HE BELIEVES THIS IS WHAT LEAD TO THE PATIENT HAVING AN INFECTION. RFNA WAS EXPLANTED AND ANTIBIOTIC SPACER WAS PLACED.

  Patient problems: Hematoma; Pulmonary Embolism; Unspecified Infection; Wound Dehiscence

  MAUDE report 14111402 ↗

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