NA 04.043.255SRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982297822), received between Jun 19, 2023 and Mar 28, 2025 — classified as 4 injuries.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMar 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, PATIENT UNDERWENT HARDWARE REMOVAL (TIBIAL NAIL ADVANCED) ON THE RIGHT TIBIA DUE TO NON-UNION. NO FRAGMENTS WERE GENERATED.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 21722448 ↗
• InjuryJan 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY ID: DEPUY - (B)(4). SUBJECT ID: (B)(4). IT WAS REPORTED THAT THE PATIENT EXPERIENCED DELAYED WOUND HEALING WITH POSSIBLE RELATION TO STUDY DEVICE AND POSSIBLE RELATION TO STUDY PROCEDURE. SURGICAL INTERVENTION OF INCISION AND DEBRIDEMENT WAS PERFORMED. THIS REPORT IS FOR ONE (1) TIBIAL NAIL-ADVANCED / 10 405 / STERILE. THIS IS REPORT 1 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: Impaired Healing; Unspecified Infection

  MAUDE report 18554132 ↗
• InjuryJan 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY ID: DEPUY - (B)(6). SUBJECT ID: (B)(6). ADVERSE EVENT TERM: TYPE I OR II OPEN FRACTURE OF LEFT TIBIA WITH DELAYED HEALING. THIS IS NOT A WORSENING OF AN EXISTING EVENT. TYPE OF EVENT: LOCAL/FRACTURE SITE. DEVICE: TNA. THERE WAS SERIOUS ADVERSE EVENT. SEVERITY: SEVERE. THIS REPORT IS FOR ONE (1) TIBIAL NAIL-ADVANCED / 10 405 / STERILE. THIS IS REPORT 1 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture; Unspecified Infection

  MAUDE report 18434864 ↗
• InjuryJun 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY ID: DEPUY - (B)(6) SUBJECT ID: (B)(6) ADVERSE EVENT TERM: HETEROTOPIC OSSIFICATION OF LEFT TIBIA DEVICE: TNA SEVERITY: MODERATE TYPE OF EVENT: LOCAL/FRACTURE SITE IS THIS A WORSENING OF AN EXISTING EVENT? NO OUTCOME: RECOVERED/RESOLVED THIS REPORT IS FOR A TIBIAL NAIL-ADVANCED / 10MM 405MM / STERILE. THIS IS REPORT 1 OF 12 FOR (B)(4).

  Patient problems: Extraskeletal ossification

  MAUDE report 17153986 ↗

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