NA 04.045.076SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982294609), received between Nov 27, 2023 and Nov 27, 2023 — classified as 1 malfunction.

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

• MalfunctionNov 27, 2023Migration; Migration

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6)-2023, THE PATIENT UNDERWENT THE ORIF WITH THE NUT AND THE SCREW FOR THE DISTAL FEMORAL FRACTURE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER SURGERY, FIXATION STRENGTH WAS CONFIRMED BY X-RAY. ON (B)(6)-2023, X-RAY SHOWED THAT THE TWO NUTS HAD DISLOCATED FROM THE SCREW ON THE MEDIAL SIDE AND THE SCREW WAS IN THE PROCESS OF DISLOCATING FROM THE NUT ON THE LATERAL SIDE. A REVISION SURGERY WAS SCHEDULED AND PERFORMED ON (B)(6)-2023, RFNA+SLP AND LCP WERE USED FOR IMPLANTS. THE SIDE LOCKING PLATES AND SCREW INSERTION WERE PERFORMED AS AN ADDITIONAL PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A LOCKING SCREW FOR IM NAIL Ø 5MM/ 76MM/ XL25/ STERILE. THIS IS REPORT 3 OF 5 FOR (B)(4)

  Patient problems: Insufficient Information

  MAUDE report 18212008 ↗

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