NA 04.233.041SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982289421), received between May 3, 2023 and Sep 9, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Use of Device Problem” (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.

• InjurySep 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). IT WAS REPORTED CLINICAL ADVERSE EVENTS WERE RECEIVED FOR BREAKAGE OF SCREWS AND NON-UNION. EVENT OCCURRED BETWEEN 3 MONTHS AND 12 MONTHS POSTOP. PATIENT STATUS/ OUTCOME: PATIENT RECOVERED WITHOUT PERSISTENT DAMAGE. THIS REPORT IS FOR ONE RFNA / 10MM / 400MM / PPFX BEND/ STER. (B)(4) IS RELATED TO (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 20173778 ↗
• MalfunctionMay 3, 2023Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT ON (B)(6), THE SURGEON HAD IMPLANTED A NAIL THAT WAS TOO LONG/PROUD. OPTIONS WERE GIVEN TO EXCHANGE THE NAIL FOR A SHORTER ONE, BUT THE SURGEON DECIDED TO STAY WITH THE LONGER NAIL. BECAUSE OF THE NAIL BEING TOO LONG, THE SURGEON WAS UNABLE TO GET ALL FOUR DISTAL INTERLOCKING SCREWS. NO ADVERSE EVENTS OR COMPLAINTS AGAINST THE DEVICES WERE MADE. THERE WAS NO PATIENT OUTCOMES REPORTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH UNKNOWN SURGICAL DELAY. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) RFNA / 10 / 400 10 DEG BEND / STERILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16861940 ↗

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