NA 04.045.340TSRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982301383), received between Sep 24, 2026 and Sep 24, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (2 reports).

2 other recalls cover devices cleared under the same FDA submission (K201336, K201346); 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Manufacturing, Packaging or Shipping Problem

  It was reported the surgeon had some difficulty determining the correct screw length to use during a procedure. The surgeon originally inserted a 34mm Screw, but imaging showed it was too long. After removing the Screw, it measured 46mm. Two 40mm Screws were opened and manually measured as 38mm. Ultimately the surgeon opened and implanted a 42mm Screw. The procedure was completed with a thirty (30) minute delay and no harm to the person.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50884626 ↗
• MalfunctionSep 24, 2026Manufacturing, Packaging or Shipping Problem

  It was reported the surgeon had some difficulty determining the correct screw length to use during a procedure. The surgeon originally inserted a 34mm Screw but imaging showed it was too long. After removing the Screw it measured 46mm. Two 40mm Screws were opened and manually measured as 38mm. Ultimately the surgeon opened and implanted a 42mm Screw. The procedure was completed with a thirty (30) minute delay and no harm to the person.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50884617 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K201336, K201346. 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 Adva
• 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