MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS SYMBOTEX; MESH, SURGICAL, POLYMERIC

Model Number SYM15

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/15/2018

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, while fixation of the mesh on laparoscopic ventral hernia, the nurse reported the mesh would tear as tacks were placed.Multiple tackers were used because the mesh was tearing.Another device had to be opened to complete the case.There was no patient injury.

Manufacturer Narrative

Evaluation summary: the device was not returned for investigation however pictures were provided.The visual examination of the provided pictures shows a mesh in vivo with a similar knitting pattern than symbotex meshes.3 pictures are provided showing parts of the mesh fixed with absorbable tacks.A hole of around 2 stitches seems to be visible in the picture 2.On the pictures 2 and 3 tacks are placed at respectively 2 and 4 stitches from the edge.However due to the picture quality, it is not possible to determine how many holes were formed, where exactly they are located in the mesh, if it is a tear or a cut, and if the mesh have been overstretched or not.Without the sample a detailed investigation could not be performed.A review of the device history record has been performed and no failure or ncr that may relate to the reported conditions have been noted.It should be noted that the mesh was fixed with over 30 absorbable tacks and 8 transfacial sutures.The product ifu which accompanies each device of symbotex¿ composite mesh states in chapter ¿warnings¿ that ¿2.In order to maintain the elasticity and the porosity of the reinforcement, it is recommended that the mesh should not be overly stretched when it is being put in place.A moderate and equal tension should be applied in all directions for fixation in order to account for wound shrinkage during the healing process.¿ and in chapter ¿operating steps ¿ positioning¿ that ¿5.The edge of the reinforcement should be at least 5 cm over the edges of the defect(s).The technique used to anchor the mesh (suture or staples) is left up to the practitioner.It is suggested to fixate the mesh at a distance approximately 1 cm from the edge of the mesh.¿ the reported information is too limited to determine the root cause or most probable cause of the reported incident and/or to determine if the incident is associated with a manufacturing or component discrepancy.Based on the available information, our investigation and a complaint history review, it is not possible to determine if the manufacture of the device is suspected or not.There is no indication that there is a defective lot or that this event represents an emerging adverse quality trend.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SYMBOTEX
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): SOFRADIM PRODUCTION SAS; 116 avenue du formans; trevoux 01600 ; FR 01600
• Manufacturer (Section G): SOFRADIM PRODUCTION SAS; 116 avenue du formans; trevoux 01600 ; FR 01600
• Manufacturer Contact: lisa hernandez ; 60 middletown ave; north haven, CT 06473 ; 2034925563
• MDR Report Key: 8051376
• MDR Text Key: 126563021
• Report Number: 9615742-2018-02514
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521190368
• UDI-Public: 10884521190368
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131969
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/07/2018

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 Expiration Date: 02/28/2022
• Device Model Number: SYM15
• Device Catalogue Number: SYM15
• Device Lot Number: PRC0745X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/15/2018
• Initial Date FDA Received: 11/08/2018
• Supplement Dates Manufacturer Received: 11/13/2018
• Supplement Dates FDA Received: 12/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/28/2017
• 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