NA 04.045.034SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982294395), received between Aug 18, 2023 and Oct 23, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (1 report).

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 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 23, 2023No Apparent Adverse Event; No Apparent Adverse Event

  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. UPON PRODUCT RETURN TO THE MANUFACTURER AND EXAMINATION ON OCTOBER 11, 2023, IT WAS IDENTIFIED THAT TWO SCREWS WERE STRIPPED. THIS REPORT INVOLVES ONE LOCKING SCREW FOR IM NAIL Ø 5MM/ 34MM/ XL25/ STERILE. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17984191 ↗
• MalfunctionAug 18, 2023Tear, Rip or Hole in Device Packaging; Manufacturing, Packaging or Shipping Problem; Tear, Rip or Hole in Device Packaging; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE RECEIVED PACKAGE WAS TAPED TOGETHER, DELIVERED BY UPS. THE TOP OF THE PACKAGE WAS COMPLETELY TORN OFF AND TAPED TOGETHER. THE CONTENTS SUSTAINED PHYSICAL DAMAGE. THE AUDIT OF THE PACK SLIP SHOWED TO ONE SCREW AND NAIL MISSING. THE PACKING CONTAINER IS UNABLE TO MAINTAIN INTEGRITY DURING TRANSIT. THERE WAS NO PATIENT CONSEQUENCES/OUTCOME. THIS REPORT IS FOR ONE (1) LOCKING SCREW FOR IM NAIL Ø 5MM/ 34MM/ XL25/ STERILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17574112 ↗

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-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