NA 04.043.115SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982297594), received between Jul 28, 2023 and Oct 25, 2024 — classified as 2 malfunctions.

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

• MalfunctionOct 25, 2024Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THIS CASE INVOLVED A TIBIAL SHAFT FRACTURE. THE ENTRY POINT OF THE NAIL WAS INFRAPATELLAR BUT PLACED LOWER THAN VENTRAL EDGE OF THE TIBIAL PLATEAU TO AVOID THE PATIENT¿S GROWTH PLATES. WHILE ATTEMPTING TO REMOVE THE CONNECTING SCREW FROM THE NAIL AND INSERTION HANDLE COMBINATION, THE PRESSURE IN THE PATIENT¿S BONE CAUSED THE CONNECTING SCREW TO NOT COME OUT. IT TOOK 45 MINUTES TO GET THE CONNECTING SCREW AND ONCE IT RELEASED FROM THE NAIL, THE CONNECTING SCREW SHEARED THE TOP OF THE NAIL AND ITS THREADS OFF. BECAUSE THE NAIL¿S THREADS WERE SHEARED OFF THE TOP, THE NAIL WAS UNABLE TO BE EXTRACTED FROM THE PATIENT. THE OVERALL SURGERY TIME WAS (3) THREE HOURS AND (10) TEN MINUTES. NO OTHER INFORMATION PROVIDED FOR REPORTING,

  Patient problems: Insufficient Information

  MAUDE report 20536200 ↗
• MalfunctionJul 28, 2023Break; Break

  IT WAS REPORTED THAT THERE WAS A 9 X 285MM TIBIAL NAIL ADVANCED AND END CAP PLACED ON (B)(6) 2023. SUBSEQUENTLY, ON AN UNKNOWN DATE THE NAIL HAS BROKEN JUST DISTAL TO THE S2 HOLE. THIS REPORT INVOLVES ONE (1) UNKNOWN TIBIAL NAIL. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17414138 ↗

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-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