NA 356.717Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982195609), received between Sep 24, 2020 and Sep 9, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (3 reports).

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

• MalfunctionSep 9, 2025Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED (B)(6), 2025 THE K WIRE APPEARED BROKEN PRE-OPERATIVELY. NO PATIENT CONSEQUENCES

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23003667 ↗
• MalfunctionMar 20, 2024Material Deformation; Material Deformation

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN NETHERLANDS AS FOLLOWS: IT WAS REPORTED THAT ON MARCH 1, 2024, BEFORE THE PROCEDURE IT WAS DISCOVERED THAT THE K-WIRE 2.8MM X 460MM W/HOOK IS BENT. A NEW K-WIRE WAS USED FOR THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE AND NO SURGICAL DELAY DUE TO THE REPORTED EVENT. THIS REPORT IS FOR ONE (1) GUIDE WIRE 2.8MM LENGTH 460MM WITH HOOK THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18941944 ↗
• MalfunctionJun 10, 2021Break; No Apparent Adverse Event; Break; No Apparent Adverse Event

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE THAT THE 40CM LONG PIN USED FOR THE IMPLANTATION OF THE PROXIMAL FEMORAL NAIL ANTIROTATION (PFNA) WAS BROKEN. CONCOMITANT DEVICE: UNKNOWN PROXIMAL FEMORAL NAIL (PFNA) (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) GUIDE WIRE 2.8MM LENGTH 460MM WITH HOOK. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11974620 ↗
• MalfunctionSep 24, 2020Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING THE REMOVAL OF A TROCHANTERIC FIXATION NAIL ADVANCED (TFNA), A PART OF THE INSTRUMENT BROKE OFF. THIS WAS THE FIRST TIME THE INSTRUMENT WAS USED. THIS REPORT IS FOR ONE (1) GUIDE WIRE 2.8MM LENGTH 460MM WITH HOOK. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10581835 ↗