STRATAFIX Symmetric PDS Plus (Ethicon Inc.) — Injury
The FDA reported an injury event involving the STRATAFIX Symmetric PDS Plus, a device manufactured by Ethicon Inc. The source provides minimal detail regarding the nature or severity of the injury.
This alert affects Ethicon Inc., manufacturers of similar barbed or symmetric suture technologies, and clinical/quality personnel responsible for monitoring surgical device performance.
The classification of the event as an 'Injury' necessitates a mandatory investigation under post-market surveillance requirements. While the source does not specify a root cause, such reports typically trigger internal CAPA (Corrective and Preventive Action) evaluations to determine if the event is an isolated incident or indicates a broader manufacturing or design issue.
Quality and regulatory teams should review recent complaint logs for this specific device model to identify potential trends in injury reports. Ensure that Risk Management Files and Clinical Evaluation Reports (CER) are updated to reflect this event if it falls outside established safety profiles.
Event type: Injury. Device: STRATAFIX Symmetric PDS Plus by Ethicon Inc..
Open in openFDA / FDA.gov