Stryker KWIC Needle 6002-070-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00808232001365), received between Apr 28, 2023 and Apr 28, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Fracture” (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. 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 28, 2023Fracture; Mechanical Jam; Fracture; Mechanical Jam

  A COMPANY REPRESENTATIVE REPORTED THAT TWO NAVIGATED KWIC NEEDLES BECAME STUCK IN A PATIENT'S PEDICLE INTRA-OPERATIVELY AND AN ORTHOPEDIC SLAP HAMMER WAS REQUIRED TO EXTRACT THE KWIC NEEDLES WHICH WERE REMOVED IN ONE PIECE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A TEN MINUTE SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT. THIS REPORT CAPTURES THE SECOND OF TWO KWIC NEEDLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16839726 ↗
• MalfunctionApr 28, 2023Fracture; Mechanical Jam; Fracture; Mechanical Jam

  A COMPANY REPRESENTATIVE REPORTED THAT TWO NAVIGATED KWIC NEEDLES BECAME STUCK IN A PATIENT'S PEDICLE INTRA-OPERATIVELY AND AN ORTHOPEDIC SLAP HAMMER WAS REQUIRED TO EXTRACT THE KWIC NEEDLES WHICH WERE REMOVED IN ONE PIECE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A TEN MINUTE SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT. THIS REPORT CAPTURES THE FIRST OF TWO KWIC NEEDLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16839065 ↗
• MalfunctionApr 28, 2023Fracture; Fracture

  A COMPANY REPRESENTATIVE REPORTED THAT A NAVIGATED KWIC NEEDLE FRACTURED INTRA-OPERATIVELY AND BECAME STUCK INSIDE THE PATIENT'S PEDICLE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A SLAP HAMMER TO REMOVE THE NEEDLE WITH A 15 MINUTE SURGICAL DELAY AND NO REPORTED ADVERSE CONSEQUENCE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16839062 ↗