Quality & complianceOfficial

Stryker Spine nitinol K-wires fracture on removal due to overly deep laser markings

🇳🇱 IGJ · Thu 29 Oct 2026

VB Spine reports ES2 Spinal System Nitinol K-Wire Blunt devices have broken during removal from patients, with 16 complaints worldwide so far, according to Dutch inspectorate IGJ.

The Dutch healthcare inspectorate IGJ has published a manufacturer field safety notice covering the ES2® Spinal System Nitinol K-Wire Blunt, marketed under the Stryker Spine name. VB Spine reported that devices have fractured while being taken out of patients.

According to the notice, the manufacturer's investigation found that certain laser markings on the wires were made too deeply in the lots in scope. The source does not specify which lots are affected, and the summary does not detail the manufacturer's corrective actions.

As of the date of the notification, 16 complaints worldwide had been linked to the problem. The notice does not state in the available text whether any patient injuries resulted, though a fracture on removal could leave fragments in the patient.

The manufacturer is listed as Stryker Spine, with Emergo Europe named as its authorised representative. The notice is dated 20 October 2026, and IGJ's listing carries a 30 October 2026 warning date. The English-language document runs to four pages.

Under the regulatory framework, manufacturers must track devices after they reach the market and act where users are at risk. They inform users and the inspectorate through a field safety notice.

What it means for your team

  • Hospitals and distributors should check stock against the lot numbers in the full field safety notice, which the IGJ summary does not list.
  • Quality and vigilance teams should review any complaints or incident reports of K-wire breakage on removal and consider whether they relate to this issue.
  • Regulatory teams should obtain the four-page notice to confirm the required user actions and any reporting expectations.
  • Manufacturers of similar nitinol wires may wish to review how laser marking depth is controlled in production.

Official source: IGJ ↗

Article written by VigiEye from the official source (IGJ). AI-assisted; check the source before acting.

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