Medartis TriLock Scaph plate bent the wrong way, field safety notice issued
The Dutch inspectorate has published a manufacturer warning on a Medartis scaphoid plate whose locking contours ended up on the convex underside after being bent in the wrong direction.
The Dutch Health and Youth Care Inspectorate (IGJ) has published a manufacturer warning concerning a Medartis AG product, the 1.2/1.5 TriLock Scaph.Pl 3x2H Large, t0.8. The notice is dated 3 November 2026, and the manufacturer's field safety notice (FSN) carries the date 16 October 2026.
According to the source, the plate was bent in the wrong direction. As a result, the locking contours sit on the underside, the convex side, of the plate rather than where they would be expected. The notice is classed as a manufacturer warning and not as an inspectorate-issued measure.
The IGJ page links to an eight-page PDF of the warning, listed in English as 'Medartis AG TriLock Scaph Pl'. The text available here does not describe affected lot numbers, the number of devices involved, any reported patient harm or the specific corrective actions requested of users.
As general context, manufacturers must monitor devices once on the market and act where a risk to users arises. They inform users and the competent authority through a field safety notice.
What it means for your team
- Quality and vigilance teams at hospitals and distributors in the Netherlands should check the full FSN PDF for affected lots and required actions, as the summary gives none.
- The defect is a manufacturing or forming error, so manufacturers of similar bent or contoured implants may want to review in-process shape and orientation checks.
- Device vigilance staff should confirm whether any stock of the named plate is held and whether the FSN has been acknowledged and recorded internally.
Article written by VigiEye from the official source (IGJ). AI-assisted; check the source before acting.
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