MAUDE Adverse Event Report: B. BRAUN SURGICAL, S.A. MONOSYN UNDYED 3/0 (2) 70CM DSMP24(M)RCP; SYNTHETIC ABSORBABLE MONOFILAR SUTURE

Model Number C2023635

Device Problems Material Fragmentation (1261); Dull, Blunt (2407); Material Twisted/Bent (2981)

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

Event Date 09/28/2020

Event Type  malfunction  

Manufacturer Narrative

Reported device not marketed in the u.S., however, similar devices or devices that share components, raw materials, process methods or other technological characteristics are registered within the u.S., k011375.If additional information becomes available a follow-up report will be submitted.

Event Description

It was reported an issue with monosyn suture.The client reported that a patient undergoing routine surgery and was about currently skin closure of the wound with a monosyn suture.When the surgeon returned the suture, it looked like it either blunted off or a little portion of the tip sheared off.There was no patient harm.Asked the surgeon to double check the area nearby if they can see any potential remnant of the tip as it looked like it has sheared off.The surgeon reported that there is no visible sign.It was compared to a new suture to see if there is any difference in length but there was a very small difference and the suture was slightly bent so unable to ascertain the exact length if it has sheared or just blunted from use.The responsible consultant was phone to ask for advice to which he said, check the area near the wound, open the skin layer suture to check inside, if unable to see, to wash and continue suturing.Upon doing the recommendation from the consultant, there was no visible sign of the tip so the patient was sutured again.Surgeon used direct vision to search and found nothing.All reasonable efforts were made to check the wound for any possible remnants of the suture.

Manufacturer Narrative

Analysis and results: there are no previous complaints of the same code-batch, of which were manufactured and distributed in the market (b)(4) units.There are no units in stock in b.Braun surgical's warehouse.We have not received any sample for analysis.Without any sample, we cannot carry out an analysis in order to take a decision.Remarks: 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.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.We have also reviewed the complaint history record, and there are no previous complaints in any of the other products manufactured with the same needle raw material batches used in this product.Final conclusion: without samples, we are not in position of studying if the involved 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 analyze it.Anyway, according to the batch manufacturing record review, the product complies with our specifications and also fulfill usp/ep requirements.Therefore, we do not see any manufacturing fault or material defect that could have caused the incidence.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: MONOSYN UNDYED 3/0 (2) 70CM DSMP24(M)RCP
• Type of Device: SYNTHETIC ABSORBABLE MONOFILAR SUTURE
• Manufacturer (Section D): B. BRAUN SURGICAL, S.A.; carretera de terrassa 121; rubí, barcelona 08191 ; SP 08191
• MDR Report Key: 11594008
• MDR Text Key: 261981435
• Report Number: 3003639970-2021-00103
• Device Sequence Number: 1
• Product Code: GAM
• Combination Product (y/n): N
• PMA/PMN Number: SEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C2023635
• Device Catalogue Number: C2023635
• Device Lot Number: 120211
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1