NA 04.045.780SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982296108), received between Aug 15, 2023 and May 26, 2025 — classified as 3 injuries.

2 other recalls cover devices cleared under the same FDA submission (K201346); 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMay 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH A RETROGRADE FEMORAL NAIL ADVANCED (RFNA) ON (B)(6) 2025. AN OPEN REDUCTION AND RETROGRADE INTRAMEDULLARY NAILING OF THE LEFT FEMUR SURGERY OCCURRED ON (B)(6) 2025. POST-OPERATIVELY X-RAYS SHOWED SIGNIFICANT BACK-OUT AND THE SCREW WAS PROMINENT. THE PATIENT HAD LIMITED FRACTURE HEALING AT THAT POINT, SO THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2025, FOR SCREW EXCHANGE AND PLACEMENT OF A LOCKING NUT THAT THREADS ONTO THE SCREW. LATER IT WAS DISCOVERED THAT THE LOCKING NUT AND SCREW WERE DISENGAGED, AND THE SCREW WAS PARTIALLY BACKED OUT. ON (B)(6) 2025, ANOTHER SURGERY WAS PERFORMED FOR LEFT FEMUR REMOVAL OF HARDWARE, REVISION OF IM NAILING. POST-OPERATIVE FOLLOW-UP INDICATE THAT THE PATIENT APPEARS STABLE, AND IMAGING SHOWED NO LOOSENING OR FAILURES AT THE PRESENT TIME; THE FRACTURE ALIGNMENT REMAINS STABLE. THIS REPORT CAPTURES THE THIRD REMOVAL EVENT THAT OCCURRED ON (B)(6) 2025. THE FIRST REMOVAL EVENT THAT OCCURRED ON (B)(6) 2025, IS CAPTURED ON RELATED COMPLAINT (B)(4). THE SECOND REMOVAL EVENT THAT OCCURRED ON (B)(6) 2025, IS CAPTURED ON RELATED COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 22084145 ↗
• InjuryAug 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6), 2022 THE PATIENT SUSTAINED INJURIES AS A RESULT OF TRIP AND FALL OVER A SECURITY BAND ON THE EXTERIOR SIDEWALK PREMISES OF THE STORE. AFTER A MECHANICAL FALL FROM STANDING, IMAGING SHOWED RIGHT DISTAL FEMUR FRACTURE AND LEFT PROXIMAL HUMERUS FRACTURE. ON (B)(6), 2022 THE PATIENT UNDERWENT IMN OF RIGHT FEMUR. OPEN REDUCTION INTERNAL FIXATION (ORIF) OF LEFT HUMERUS FRACTURE ON (B)(6), 2022. HE WAS DISCHARGED TO FOR ACUTE REHAB ON (B)(6), 2022. ON (B)(6), 2023 THE PATIENT WAS ADMITTED FOR RIGHT FEMUR NONUNION REVISION, WITH WORSENING RIGHT THIGH PAIN AND IMPAIRED MOBILITY. THE PATIENT HAD ANTIBIOTIC MANAGEMENT OF RIGHT FEMORAL OSTEOMYELITIS. THIS REPORT IS FOR A WASHER FOR SCREW 14/7MM STERILE FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture; Pain; Unspecified Infection

  MAUDE report 17548116 ↗
• InjuryAug 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6), 2022 THE PATIENT SUSTAINED INJURIES AS A RESULT OF TRIP AND FALL OVER A SECURITY BAND ON THE EXTERIOR SIDEWALK PREMISES OF THE STORE. AFTER A MECHANICAL FALL FROM STANDING, IMAGING SHOWED RIGHT DISTAL FEMUR FRACTURE AND LEFT PROXIMAL HUMERUS FRACTURE. ON (B)(6), 2022 THE PATIENT UNDERWENT IMN OF RIGHT FEMUR. OPEN REDUCTION INTERNAL FIXATION (ORIF) OF LEFT HUMERUS FRACTURE ON (B)(6), 2022. HE WAS DISCHARGED TO FOR ACUTE REHAB ON (B)(6), 2022. ON (B)(6), 2023 THE PATIENT WAS ADMITTED FOR RIGHT FEMUR NONUNION REVISION, WITH WORSENING RIGHT THIGH PAIN AND IMPAIRED MOBILITY. THE PATIENT HAD ANTIBIOTIC MANAGEMENT OF RIGHT FEMORAL OSTEOMYELITIS. THIS REPORT IS FOR A WASHER FOR SCREW 14/7MM STERILE FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture; Pain; Unspecified Infection

  MAUDE report 17548058 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K201346. One submission often covers many models, so check the product and lot details in each record.

• 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
• 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