Patient safety is one of the fundamental pillars of surgical care and is strongly influenced by the quality of the supplies used, including suture threads. Resolution RDC No. 36/2013 of the Agência Nacional de Vigilância Sanitária (ANVISA) establishes the mandatory reporting of adverse events related to health products. From September 2024 onward, a hospital in the city of Manaus (AM) observed a significant increase in cases of surgical wound dehiscence and thread rupture during surgical procedures, with reports from different specialties. This scenario raised suspicions regarding the quality of the standardized surgical threads used in the institution. The first occurrences were identified in general surgery procedures, with records of thread rupture during the intraoperative period. In total, 24 episodes of failures in thread integrity were documented, including an extreme case in which 13 threads ruptured during a single procedure. Simultaneously, notifications of surgical wound dehiscence began to be reported in patients already in the postoperative period, including an episode of early incision opening with signs of local infection on the day following suture removal. A total of 11 notifications of dehiscence associated with surgical site infection (SSI) were recorded. The institutional investigation identified recurrent batches with structural failures, including evidence of compromised thread integrity while still sealed in the packaging. The timeline of events showed progression of the outbreak with a peak incidence from December 2024 onward. The failure in the quality of surgical threads exposed patients to clinical risks and relevant care-related impacts, such as the need for surgical reinterventions and prolonged recovery time. The rapid institutional response, with suspension of the batches, quarantine of stock, and notification to regulatory agencies, highlights the importance of supply traceability, active surveillance, and the need for rapid responses to adverse events. In addition, it reinforces the urgency of a careful review of contracts in the context of corporate procurement.
Cerbaro et al. (Sun,) studied this question.