NA 04.233.920SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982288523), received between Oct 11, 2022 and May 2, 2023 — classified as 1 injury, 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 (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.

• MalfunctionMay 2, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT A PRIMARY SURGERY WITH LCP-DF IMPLANTS. AFTER THE INITIAL SURGERY ON (B)(6) 2023, REMOVAL OF LCP-DF IMPLANTS WAS PERFORMED AND A REVISION WITH NAIL AND TKA WAS PERFORMED. DURING REMOVAL OF THE LOCKING SCREWS, THE TWO PROXIMAL SCREWS WERE DIFFICULT TO REMOVE AND REQUIRED USE OF A CARBIDE DRILL TO EXTRACT. WHILE DRILLING FOR THE 2ND MOST PROXIMAL SCREW OF THE RFNA NAIL, THE DRILL BIT INTERFERED WITH THE NAIL. THE DRILLING WAS ATTEMPTED AGAIN AFTER DRILLING THE FURTHEST PROXIMAL SCREW, BUT THE BIT MISSED THE HOLE IN THE NAIL. THEREFORE, TWO PEOPLE HELD THE PATIENT¿S FEMUR IN PLACE TO PREVENT MOVEMENT, AND THE SURGEON DRILLED WITH SLEEVES AND WERE ULTIMATELY ABLE TO INSERT THE TWO SCREWS REQUIRED. AFTER COMPLETING RFNA NAIL INSERTION, THE SURGEON PERFORMED TKA. THE PROCEDURES WERE COMPLETED SUCCESSFULLY WITH 30 MINUTES OF SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A RFNA / 9MM / 200MM 5 DEGREE BEND / STERILE. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16854727 ↗
• InjuryOct 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON AN UNKNOWN DATE THAT INTERIM REPORT SUBMITTED AS PART OF AN INVESTIGATOR INITIATED STUDY (IIS) FOR THE RETROGRADE FEMORAL NAIL ADVANCED. THE REPORTS ADVERSE EVENTS ASSOCIATED WITH THE RETROGRADE FEMORAL NAIL ADVANCED. THE INTERNAL ID FOR THE IIS IS (B)(4). THIS REPORT IS FOR ONE (1) UNK - NAILS: RFNA. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

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

  MAUDE report 15574930 ↗

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