NA 04.043.330SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982298225), received between Feb 20, 2025 and Apr 1, 2025 — classified as 2 malfunctions.

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); 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.

• MalfunctionApr 1, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2025, THE DISTAL NAIL WAS DEFORMED AND WAS UNUSABLE. SURGEON HAD TO EXTRACT THE NAIL.

  Patient problems: Insufficient Information

  MAUDE report 21739421 ↗
• MalfunctionFeb 20, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SURGEON WAS DOING A TIBIAL NAIL ADVANCED AND AFTER INSERTING THE NAIL INITIALLY, THEY BACKSLAPPED THE NAIL OUT TO REDIRECT IT. WHEN IT CAME OUT, THEY WERE CHECKING TO MAKE SURE THE INLAY WAS STILL LINING UP WITH THE SCREW HOLES. THIS IS WHEN THEY NOTICED THAT THE PEEK INSERT WAS NO LONGER IN THE DISTAL PORTION OF THE NAIL. THE SURGEON PUT A GUIDE ROD THROUGH THE NAIL TO SEE IF THE INLAY HAD BEEN PUSHED INTO THE NAIL, BUT NOTHING CAME OUT OF THE NAIL TO INDICATE THIS HAD HAPPENED. THEY WERE NOT ABLE TO LOCATE THE INLAY AND PUT THE NAIL BACK IN WITHOUT IT. THE PROXIMAL INLAY WAS ALSO ROTATED AFTER BACKSLAPPING AND HAD TO BE REALIGNED TO MATCH THE HOLES.

  Patient problems: Insufficient Information

  MAUDE report 21426322 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K201336. 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