NOVOSYN QUICK UNDY 3/0(2)70CM DS19(M)DDP

Description of Event or Problem

It was reported an issue with Novosyn Quick suture.The client reported that 15 patients out of approximately 20 treated over a period of about 15 days, had local skin reaction.Patient age: 45-70 years, both genders.Types of procedures:Carpal tunnel release.Trigger finger surgery.Thumb carpometacarpal (CMC) arthroplasty for rhizarthrosis.Radius fracture repair.Based on discussions with the physician, the reported issue mainly concerns local reactions characterized by the appearance of small papules along the wound margins, which subsequently suppurate and resolve spontaneously. One case of complete wound dehiscence was also reported; the clinician hypothesizes that a possible cause may be a faster-than-expected absorption of the suture.Additional information:Today we were informed that the remaining sutures from the referenced batch have been disposed of. Therefore, no samples are available. As previously mentioned, the local reactions consisted of the appearance of small papules along the wound margins, which subsequently suppurated and resolved spontaneously. The complete wound dehiscence was re-sutured using the same type of suture but from a different batch, and no further issues were observed.

Additional Manufacturer Narrative

Summary of investigation:There is one previous complaint of this code-batch regardinganother issue (thread broke during surgery) closed as not confirmed. Wemanufactured and distributed in the market (b)(4) units. There are nounits in our stock. We have received 15 cases of the same code-batch, 14regarding the same issue (skin reaction) and 1 regarding another issue(wound dehiscence), from the same customer, at the same time.We have not received any sample for analysis.Without closed and/or defective samples a proper analysis cannot be carried out.According to the Side Effects of the Instructions for use (IFU) of the product: 'As with any other suture, after implantation, the followingside effects may occasionally occur: transient inflammatory foreign body reaction, transient local irritation, granulation, stitch sinus, infection at the wound site or impaired aesthetic outcomes. Existing infections may occasionally be enhanced by any foreign body. The degradation of the suture may also be slightly accelerated depending on the patient and the severity of infection.May not be excluded occasional pain, granuloma, seroma, fibrotic scar, hardening of tissues (subcuticular tissues), irritation, hematoma, suture rejection, infection, wound dehiscence and hemorrhage or leakage.Batch Manufacturing Record:Reviewed the batch manufacturing record, this product had no incidences related to this issue and was released fulfilling USP/EP and B. Braun Surgical specifications. Furthermore, Knot pull tensile strength results conducted on samples before releasing the product were 1.46 kgf in average and 1.40 kgf in minimum and fulfilled the requirements of the European Pharmacopoeia (EP): 1.27 kgf in average and 0.76 kgf in minimum. Degradation test results conducted on samples beforereleasing after 7 days in a Sörensen solution at 37ºC were 0.38 kgf inminimum and 0.44 kgf in maximum and fulfil BBS requirement: 0.23 kgf inminimum and 0.96 kgf in maximum.Conclusion Root Cause Analysis:It has not been possible to determine the root cause because no samples have been received.Final conclusion:Without samples we are not in position to study 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, we take note of this incidence and if any sample is received in the future, we will re-open the case and analyse it. Please note that when no samples are received our analysis is very limited.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.