NA 04.233.916SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982288516), received between Oct 19, 2022 and Oct 19, 2022 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryOct 19, 2022Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PHYSICIAN REPORTED THAT A SHORT RFNA WHICH HE HAD IMPLANTED ON (B)(6) 2022 HAD BROKEN AT THE JUNCTION BETWEEN THE MOST DISTAL SCREW OF THE PROXIMAL INTERLOCKING SCREWS. THE SURGEON REMOVED THE BROKEN HARDWARE ON (B)(6) 2022 AND REVISED THE CONSTRUCT WITH A NAIL AND PLATE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE RFNA / 9MM / 160MM 5 DEGREE BEND / STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 15633871 ↗

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-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