NOVOSYN

Description of Event or Problem

It was reported an issue with Novosyn suture.The origin of these cases derives from a Survey: B. Braun Novosyn sutures- Post Marketing Clinical Follow Up.The reported cases correspond to adverse events or complications encountered and suture not performing as expected, when using B. Braun Novosyn sutures encountered within the 30 days preceding the survey (that took place between November 2022 and January 2023).Tissue types where B. Braun Novosyn® sutures were used are fascia, ligation, multiple layers, mucosa, superficial skin, intra-dermal, peritoneum, gastrointestinal anastomosis, cornea or sclera, meshfixation, conjunctiva and episiotomy.The specific product code and batch number involved in each individual case is not known.Urologic surgeon.Adverse event description: Foreign body reaction (including granuloma)in Urologic surgery. Indication: Ligation.Adult patients (elderly patients (>65 years) Granuloma. Did not require re-operation.

Additional Manufacturer Narrative

Summary of investigation:Without code and batch number, we cannot check the information regarding product stock or batch manufacturing records.Without closed samples and/or defective samples a proper analysis cannot be performed.Batch Manufacturing Record:Not possible to check.Conclusion Root Cause Analysis:Root cause: Not applicable, granuloma is an expected undesirable side-effect documented in the Instructions for use of the product.Final conclusion:Without samples we are not in position of studying if the affected product does not fulfil the specifications. In consequence, a proper analysis cannot be done, and the case is not confirmed due to lack of evidence. Nevertheless, granuloma is an expected undesirable side effect documented in the instructions for use of the product:Side effectsAn existing infection may be negatively influenced by any absorbable suture.The degradation of the suture may also be slightly accelerated depending on the patient and the severity of infection.The following side effects may be associated with the use of this product: pain, granuloma, seroma, hematoma, rejection, enhanced bacterial infectivity, wound dehiscence, anastomotic leak and haemorrhage.Corrective measures:Actions on distributed product of this reference/batch: Based on the conclusion derived from investigation, it is not required to make actions in distributed product.Corrective/Preventive actions: According to our internal procedures, there is no need to establish corrective or preventive actions. Nevertheless, this complaint is recorded for trending analysis to assess if actions are needed in the future.