NA 04.045.060Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982292933), received between Jun 17, 2021 and May 26, 2025 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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 4 most recent of 4 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 22084194 ↗
• MalfunctionJan 5, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT A TNA PROCEDURE WITH SUPRAPATELLAR APPROACH. THE PROXIMAL ANTERIOR TO POSTERIOR 0 DEGREE SCREW MISSED THE NAIL WHEN ATTEMPTING TO INSERT IT USING THE AIMING ARM AND THE TRIPLE GUIDE SLEEVES. THE SURGEON DRILLED THROUGH THE SLEEVES, BUT THE BIT DID NOT ALIGN WITH THE SCREW HOLE AND WENT MEDIAL TO THE NAIL. THE SCREW THAT WAS INSERTED FOLLOWED THE SAME PATH AND MISSED THE NAIL. THE SCREW WAS REMOVED, AND THE SURGEON DID NOT USE THAT SCREW HOLE. THERE WAS NO SURGICAL DELAY, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE LOCKING SCREW FOR IM NAIL Ø 5MM/ 60MM/ XL25. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16102752 ↗
• InjuryJan 28, 2022Migration; Migration

  IT WAS REPORTED THAT ON UNKNOWN DATE, PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE. IT WAS NOTED THAT THE DISTAL SCREW BACKING OUT OF RFNA NAIL. AN X-RAY TAKEN FIVE (5) WEEKS POST OPERATION SHOWED THE DISTAL SCREW BACKED OUT. IT IS UNKNOWN IF HOW THE PROCEDURE WAS COMPLETED. THERE WAS PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) LOCKING SCREW FOR IM NAIL Ø 5MM/ 60MM/ XL25. THIS IS REPORT 2 OF 2 FOR (B)(4).

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

  MAUDE report 13385247 ↗
• InjuryJun 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6)2021, PATIENT UNDERWENT A REVISION DUE TO LOSS OF FIXATION. WE WERE MADE AWARE OF A REVISION OF IMPLANTS THAT'S SHOULD BEEN IMPLANTED ON (B)(6)2021. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY REPORTED. PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES (7) DEVICES. THIS REPORT IS FOR (1) LOCKING SCREW FOR IM NAIL 5/ 60/ XL25. THIS REPORT IS 4 OF 7 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 12021136 ↗

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