MAUDE Adverse Event Report: B. BRAUN SURGICAL, S.A. NOVOSYN QUICK UNDY 3/0(2)70CM DS24(M)DDP; SYNTHETIC ABSORBABLE BRAIDED SUTURE

Model Number C3046235

Device Problem Dull, Blunt (2407)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/19/2023

Event Type  malfunction  

Manufacturer Narrative

Analysis and results: there are no previous complaints of this code-batch.We manufactured and distributed in the market (b)(4) units of this code-batch.There are no units in our stock.We have not received any sample for analysis.Without any closed and/or defective sample we cannot carry out an analysis in order to take a decision.Reviewed the batch manufacturing record, this product had a normal process and the results during the process fulfil usp/ep and b.Braun surgical requirements.Needle penetration performance (1st penetration) results of needles tested of each raw material batch used in this product during production were 0.414 n, 0.363 n, 0.331 n and 0.352 n in average and fulfilled the specification (<0.480 n).Additionally, reviewed the complaint history record, there are no other complaints in any of the products manufactured with the same needle nor thread raw material batches that have been used in this product.As stated in the instructions for use of the product, when working with novosyn®quick suture material great care should be taken in order to ensure that the surgical instruments used, such as forceps or needle holders do not cause any crushing or crimping damage to the suture material.Also, care should be taken to avoid damage when handling surgical needles.Grasp the needle in an area one-third (1/3) to one-half (1/2) of the distance from the attachment end to the point.Grasping in the point area could impair the penetration performance and cause fracture of the needle.Grasping at the butt or attachment end could cause bending or breakage.Reshaping needles may cause them to lose strength and be less resistant to bending and breaking.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, 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.We regret any inconvenience this issue may have caused and thank you for your collaboration.Actions on product distributed 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.

Event Description

It was reported an issue with novosyn quick suture.The client reported that the needle not able to perforate the skin at first suture stitch, the thread did not slides well, it is weak and frayed.No injury, no consequences.No further information has been provided.

Manufacturer Narrative

Analysis and results: there are no previous complaints of this code-batch.We manufactured and distributed in the market (b)(4) units of this code-batch.There are no units in stock at b.Braun surgical's warehouse.We have received six closed samples for analysis.Tightness test to the closed samples received has been performed and the units are tight.The needles of three of the closed samples received have been analyzed for penetration performance test and the results for each needle are 0.445 n, 0.423 n and 0.470 n in average for the 1st penetration.These values fulfill the needle specification of 0.480 n in maximum for the 1st penetration.Reviewed the needle batch manufacturing records, no deviations have been found and the results of penetration performance test for each needle raw material batch used in this product during production were 0.414 n, 0.363 n, 0.331 n and 0.352 n in average for the 1st penetration and fulfilled the specification (<0.480 n).Sewing test on artificial skin tissue has been conducted with the other three closed samples received and fraying does not appear when pulling the thread through the tissue.Visual appearance of the thread before and after sewing test is the usual one as can be seen in enclosed picture.Reviewed the batch manufacturing record, this product had a normal process and the results during the process fulfilled usp/ep and b.Braun surgical requirements.We have also reviewed the complaint history record, and there are no previous complaints in any of the products manufactured with the same needle nor thread raw material batches used in this product.Remarks: as stated in the instructions for use of the product, when working with novosyn®quick suture material great care should be taken in order to ensure that the surgical instruments used, such as forceps or needle holders do not cause any crushing or crimping damage to the suture material.Also, care should be taken to avoid damage when handling surgical needles.Grasp the needle in an area one-third (1/3) to one-half (1/2) of the distance from the attachment end to the point.Grasping in the point area could impair the penetration performance and cause fracture of the needle.Grasping at the butt or attachment end could cause bending or breakage.Reshaping needles may cause them to lose strength and be less resistant to bending and breaking.Based on the test results of the closed samples received from the customer and the review of the batch manufacturing record, the product complies with our specifications, so we do not see any manufacturing faults or material defects that could have caused the incidence.Final conclusion: although the results of the closed samples received fulfil the b.Braun surgical specifications, we take note of this incidence in order to assess if new or additional actions are needed.We regret any inconvenience this issue may have caused and thank you for your collaboration.Actions on product distributed 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.

• Brand Name: NOVOSYN QUICK UNDY 3/0(2)70CM DS24(M)DDP
• Type of Device: SYNTHETIC ABSORBABLE BRAIDED SUTURE
• Manufacturer (Section D): B. BRAUN SURGICAL, S.A.; carretera de terrassa 121; rubí, barcelona 08191 ; SP 08191
• Manufacturer (Section G): B. BRAUN SURGICAL, S.A.; carretera de terrassa 121; rubí, barcelona 08191 ; SP 08191
• Manufacturer Contact: martina laporte ; carretera de terrassa 121; rubí, barcelona 08191 ; SP 08191
• MDR Report Key: 17696643
• MDR Text Key: 322813275
• Report Number: 3003639970-2023-00287
• Device Sequence Number: 1
• Product Code: GAM
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K170661
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C3046235
• Device Catalogue Number: C3046235
• Device Lot Number: 123123
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/11/2023
• Initial Date FDA Received: 09/07/2023
• Supplement Dates Manufacturer Received: 10/10/2023
• Supplement Dates FDA Received: 10/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1