NA 04.045.038Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886982292766), received between Jun 7, 2021 and May 26, 2025 — classified as 6 injuries.

The most frequently reported specific device problem is “Migration” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K201336, 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 6 most recent of 6 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 22084179 ↗
• 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 22084175 ↗
• InjuryJul 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2024 PATIENT WAS BROUGHT INTO SURGERY BY SURGEON FOR A LOOSENING OF DISTAL INTERLOCKING SCREWS IN A SYNTHES RFNA FEMORAL NAIL. THE IMPLANT WAS INITIALLY PLACED BY SURGEON ON (B)(6) 2024 AT THE SAME FACILITY. AT SOME POINT AFTER THAT DATE THE PATIENTS NURSING HOME NOTICED PROMINENT HARDWARE AT THE SKIN. THE PATIENT WAS BROUGHT TO THE HOSPITAL FOR REVISION SURGERY ON (B)(6) 2024 . THERE WAS AN INFECTION. THERE WAS NO SURGICAL DELAY. THIS REPORT INVOLVES ONE (1) LOCKING SCREW FOR IM NAIL Ø 5MM/ 38MM/ XL25. THIS IS REPORT 6 OF 6 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 19806276 ↗
• InjuryJul 23, 2024Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2024 PATIENT WAS BROUGHT INTO SURGERY BY SURGEON FOR A LOOSENING OF DISTAL INTERLOCKING SCREWS IN A SYNTHES RFNA FEMORAL NAIL. THE IMPLANT WAS INITIALLY PLACED BY SURGEON ON (B)(6) 2024 AT THE SAME FACILITY. AT SOME POINT AFTER THAT DATE THE PATIENTS NURSING HOME NOTICED PROMINENT HARDWARE AT THE SKIN. THE PATIENT WAS BROUGHT TO THE HOSPITAL FOR REVISION SURGERY ON (B)(6) 2024 . THERE WAS AN INFECTION. THERE WAS NO SURGICAL DELAY. THIS REPORT INVOLVES ONE (1) LOCKING SCREW FOR IM NAIL Ø 5MM/ 38MM/ XL25. THIS IS REPORT 4 OF 6 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 19806115 ↗
• InjuryJun 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, DURING A PROCEDURE FOR TROCHANTERIC FIXATION NAIL (TFN), INTER-LOCKING SCREWS WERE REMOVED FROM A LONG TFN NAIL. REMOVAL WAS DONE WITH EASE AND NO COMPLICATIONS. THIS REPORT IS FOR ONE (1) LOCKING SCREW FOR IM NAIL ¿ 5MM/ 38MM/ XL25. THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11953433 ↗
• InjuryJun 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, DURING A PROCEDURE FOR TROCHANTERIC FIXATION NAIL (TFN), INTER-LOCKING SCREWS WERE REMOVED FROM A LONG TFN NAIL. REMOVAL WAS DONE WITH EASE AND NO COMPLICATIONS. THIS REPORT IS FOR 1 LOCKING SCREW FOR IM NAIL Ø 5MM/ 38MM/ XL25. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11953432 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K201336, 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