NA 04.043.140SRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886982297648), received between Jun 21, 2022 and Jan 5, 2026 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 reports).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 5, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE, THE PEEK-INLAY CAME OFF THE NAIL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23966884 ↗
• MalfunctionOct 31, 2025Break; Break

  IT WAS REPORTED ON AN UNKNOWN DATE, THAT WHEN ADJUSTING THE NAIL THE PEEK SLEEVE CAME OUT OF THE NAIL AND SPLIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23436780 ↗
• MalfunctionOct 15, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED ON AN UNKNOWN DATE WHILE DRILLING THE STATIC 2 HOLE ON THE ADVANCED TIBIA NAIL THE DRILL HIT THE NAIL. USER DRILLED A DIFFERENT HOLE. IT IS UNKNOWN IF FRAGMENTS WERE GENERATED. THERE WAS NO SURGICAL DELAY DUE TO THE REPORTED EVENT AND PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23280513 ↗
• MalfunctionSep 6, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON (B)(6) 2024, THE TIBIAL NAIL WAS OPENED AND IT WAS NOTICED THE PEEK INLAY WAS COVERING THE WHOLE STATIC LOCKING HOLE. A NEW NAIL WAS USED AND THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20160548 ↗
• InjuryOct 23, 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: INFECTED R TIBIA FRACTURE. IS THIS A WORSENING OF AN EXISTING EVENT? YES. CREATION DATE: (B)(6) 2023. SITE AWARENESS DATE: 26-09-2023. TYPE OF EVENT: LOCAL/FRACTURE SITE. DEVICE: TNA. IS THE ADVERSE EVENT SERIOUS? YES. SEVERITY: MODERATE. THIS REPORT IS FOR A TIBIAL NAIL-ADVANCED / 9MM 360MM / STERILE. THIS IS REPORT 1 OF 7 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 17987667 ↗
• MalfunctionJun 21, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2022, DURING A ROUTINE TIBIAL NAILING OF A MIDSHAFT TIBIA FRACTURE, THE SURGEON EXPERIENCED A PROBLEM WHERE THE AIMING ARM FOR THE PROXIMAL INTERLOCKS DID NOT LINE UP WITH THE MOST DISTAL HOLE IN THE NAIL, AND THE NAIL OBSTRUCTED THE PATH OF THE DRILL BIT. THE PATIENT¿S KNEE WAS BUMPED UP TO REMOVE TENSION AT THE NAIL/INSERTION HANDLE JUNCTION, AND THE CONNECTION POINT WAS INSPECTED AND CONFIRMED TO BE TIGHT, BUT THE ISSUE WAS NOT RESOLVED. THE AIMING ARM WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING A FREE-HAND PERFECT CIRCLE TECHNIQUE. NO PATIENT IMPACT. THIS REPORT IS FOR A TIBIAL NAIL-ADVANCED / 9MM 360MM / STERILE. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14756152 ↗

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 A
• 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