NA 04.233.428SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982291110), received between Jun 30, 2025 and Jun 30, 2025 — classified as 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 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.

• MalfunctionJun 30, 2025Break; Use of Device Problem; Break; Use of Device Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT AN UNKNOWN SURGERY FOR SUPRACONDYLAR FEMORAL FRACTURE WITH THE NAIL. SINCE THE MEDULLARY CAVITY WAS WIDE, THE NAIL WAS INSERTED MANUALLY WITHOUT REAMING, BUT ONLY AT THE END, THE NAIL WAS INSERTED TO THE INDICATED POSITION BY LIGHTLY HAMMERING SEVERAL TIMES. AFTER THAT, THE DISTAL PART WAS FIXED WITH FOUR SCREWS, AND WHEN THE PROXIMAL PART WAS CHECKED FROM THE FRONT BY FLUOROSCOPY, A CRACK-LIKE LINE WAS SEEN FROM THE TIP OF THE NAIL, BUT IT WAS NOT POSSIBLE TO BE CERTAIN, SO THE SURGERY WAS CONTINUED. WHEN THE CIRCULAR PART OF THE AP HOLE WAS DRILLED AND THE SCREWS WERE INSERTED, THE CORTICAL BONE IN FRONT WAS RAISED, AND A FRACTURE WAS CONFIRMED. THEREFORE, ALL THE NAILS AND SCREWS WERE REMOVED, REPLACED WITH A 320MM NAIL, AND FOUR DISTAL SCREWS AND TWO PROXIMAL SCREWS WERE INSERTED AGAIN, AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. AFTER THE SURGERY, THE SURGEON AND THE SALES REP DISCUSSED THE CAUSES OF THIS INCIDENT, INCLUDING A MISMATCH BETWEEN THE FEMORAL LORDOSIS AND THE NAIL SHAPE, WHICH PUT STRESS ON THE ANTERIOR CORTICAL BONE (INCLUDING HAMMERING), THE TIP WAS INSERTED IN A FORWARD DIRECTION DUE TO TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22360740 ↗

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 Adva
• 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