NA 04.233.440SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982291172), received between Jul 26, 2023 and Jul 26, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Twisted/Bent” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 26, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN (B)(6) 2023, DURING A CASE USING THE RFN-ADVANCED NAIL, THE SURGEON ASSEMBLED THE CONNECTING SCREW TO THE NAIL WITH THE INSERTION HANDLE. THE SURGEON HAD A HARD TIME INSERTING THE NAIL, AND A FEW TIMES DURING INSERTION, THE CONNECTING SCREW CAME LOOSE. THE SURGEON TRIED TO USE ANOTHER CONNECTING SCREW, BUT ALSO EXPERIENCED THE SAME THING. BOTH CONNECTING SCREW THREADS UP CLOSE, WITH NOTHING OF NOTE FROM THE IMAGE. THE SURGEON WAS ABLE TO FULLY SINK THE NAIL AND MANAGED TO GET THE AIMING ARM ONTO THE INSERTION HANDLE. THE SURGEON SUSPECTED THAT THE THREADS WITHIN THE SPECIFIC NAIL WE USED WERE FAULTY. THIS COULD HAVE RESULTED FROM EITHER DAMAGE TO THE THREADS DURING THE INSERTION OF THE NAIL, DAMAGE TO THE THREADS DURING THE INITIAL CONNECTION OF THE NAIL TO THE INSERTION HANDLE (WITH CONNECTING SCREW), OR FAULTY THREADS IN THE NAIL RIGHT OUT OF THE BOX. WE DID EXTENSIVE ANALYSIS AND TESTING OF BOTH CONNECTING SCREWS IN QUESTION, BOTH INSERTION HANDLES FROM EACH RESPECTIVE TRAY THE CONNECTING SCREW CAME FROM, AND MULTIPLE NAILS. WE FOUND NO LOOSENING, DISCONNECTION, DAMAGE, OR ANYTHING FAULTY WHATSOEVER. CONCOMITANT DEVICE REPORTED: UNK - GUIDES/SLEEVES/AI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17396660 ↗

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-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 Adva
• 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 Adva