NA 04.233.233SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982290427), received between Jan 27, 2023 and Feb 7, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (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.

• MalfunctionFeb 7, 2023Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2023, THAT THERE WAS A SCREW BACK OUT FROM RFNA OF A PATIENT WHO WAS TREATED ON (B)(6) 2022 FOR DISTAL FEMUR PERIPROSTHETIC FRACTURE. THE SURGEON PLANS TO SEE THE PATIENT AGAIN IN 5 WEEKS AND WILL DETERMINE IF SCREW REMOVAL IS REQUIRED. THERE IS NO REPLACEMENT REQUIRED AT THIS TIME. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) RFNA / 12 / 320 10 DEG BEND / STERILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 16313598 ↗
• InjuryJan 27, 2023Break; Break

  THE FOLLOWING ADVERSE EVENT WAS REPORTED FOR SUBJECT (B)(6) FOR THE DST202103 STUDY: IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY TO IMPLANT LEFT SIDE RFNA ON (B)(6)2022. ON (B)(6), 2023, IT WAS NOTED THAT THE PATIENT SUFFERED HARDWARE BREAKAGE, WHICH WILL REQUIRE REVISION SURGERY. AS OF (B)(6), 2023, REVISION HAD NOT BEEN SCHEDULED YET. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE RFNA / 12MM / 320MM 10 DEGREE BEND / STERILE. THIS IS REPORT 1 OF 8 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 16252842 ↗

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