NA 04.043.340SRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10886982298249), received between Jul 5, 2022 and May 22, 2025 — classified as 4 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 22, 2025No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT THE NAIL WAS NOTED TO BE DEFECTIVE. THE PEEK MATERIAL LOOSENED OUT OF THE NAIL, AND SURGEONS USED OTHER SIZE NAIL. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A FIFTEEN MINUTE DELAY. NO OTHER MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22072546 ↗
• InjuryAug 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY: DEPUY CLINICAL ADVERSE EVENT RECEIVED FOR INFECTED NONUNION. DEVICE RELATEDNESS: NO INFORMATION PROVIDED. PROCEDURE RELATEDNESS: NO INFORMATION PROVIDED. DATE OF EVENT: NO INFORMATION PROVIDED. DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: SURGICAL INTERVENTION AT THE FRACTURE SITE. DEPUY SYNTHES PRODUCTS USED: TNA. THIS REPORT IS FOR A TIBIAL NAIL-ADVANCED / 11MM 360MM / STERILE. THIS IS REPORT 1 OF 9 FOR (B)(4).

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

  MAUDE report 20030508 ↗
• MalfunctionFeb 19, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON (B)(6) 2024, WHEN INSERTING TIBIAL NAIL ADVANCED OVER A 3.0MM REAMING ROD, THE POLYMER INLAY CAME OUT. THE SURGEON HAD TO REMOVE THE NAIL OFF OF THE INSERTION HANDLE AND IMPLANT ANOTHER TIBIAL NAIL. THE NAIL HAD TO BE TAKEN OFF INSERTION HANDLE AND POLYMER INLAY WAS REMOVED WHEN TRYING TO DETERMINE WHAT THE PROBLEM WAS. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A SURGICAL DELAY OF 10 MINUTES. THIS REPORT IS FOR ONE (1) TIBIAL NAIL-ADVANCED / 11 360 / STERILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18731063 ↗
• MalfunctionAug 1, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6), 2023 THAT THE BALL TIP OF THE GUIDE WIRE WOULD NOT COME OUT OF THE NAIL. THE GUIDE WIRE WAS CAUGHT UP ON THE PROXIMAL PEEK PIECE IN THE NAIL. SURGEON HAD TO PULL OUT THE NAIL AND GET A NEW ONE. THERE WAS 30 MINUTES SURGICAL DELAY. PROCEDURE WAS COMPLETED SUCCESSFULLY. FRAGMENTS WERE GENERATED AND IT WAS REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) TIBIAL NAIL-ADVANCED / 11 360 / STERILE. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17436072 ↗
• InjuryMay 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT: (B)(6). ADVERSE EVENT TERM: NONUNION. IS THIS A WORSENING OF AN EXISTING EVENT? NO. SITE AWARENESS DATE: 06-04-2023. TYPE OF EVENT: LOCAL/FRACTURE SITE. SIDE: LEFT. DEVICE: TNA. SEVERITY: MODERATE. IS THE ADVERSE EVENT SERIOUS? YES. THIS REPORT IS FOR A TIBIAL NAIL-ADVANCED / 11MM 360MM / STERILE. THIS IS REPORT 1 OF 7 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture; Pain

  MAUDE report 16863180 ↗
• InjurySep 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2022 THAT THE PATIENT EXPERIENCED A NONUNION AFTER TNA PROCEDURE, WHICH REQUIRED FURTHER SURGICAL INTERVENTION. THIS REPORT INVOLVES ONE TIBIAL NAIL-ADVANCED / 11MM 360MM / STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 15410185 ↗
• InjuryJul 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD ADVERSE EVENT OF PSEUDOMONAS. PATIENT WAS IMPLANTED WITH RFNA. THIS REPORT IS FOR ONE (1 TIBIAL NAIL-ADVANCED / 11 360 / STERILE. THIS IS REPORT 2 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: Post Operative Wound Infection

  MAUDE report 14918864 ↗

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-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