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

Model Number SYM3020

Device Problem Degraded (1153)

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

Event Date 09/19/2017

Event Type  malfunction  

Event Description

According to the reporter: during an open repair of multiple ventral and incisional hernias located on midline, surgeon noticed that large chunks of the anti-adhesion barrier were falling off the mesh while he was suturing mesh into place.There were multiple defects of varying size.Suture was used as a fixation system and also used to close the wound after the procedure.There was no injury caused to the patient and no medical intervention was required.

Manufacturer Narrative

Evaluation summary: post market vigilance had led an evaluation of a photo.The visual examination of the provided picture shows 3 small pieces of blood -contaminated textile which knitting pattern could match with symbotex composite mesh.These 3 pieces have been cut and collagen film is visible on it.A review of the device history record has been performed, no failure or ncr that may relate to the reported conditions have been noted.No product was provided for evaluation.Without the sample a detailed investigation could not be performed.The root cause could not be determined based on the available information.It should be noted that collagen film are manually cut and individually visually inspected as part of the routine manufacturing process.Based on our investigation and a complaint history review, the manufacture of the device is not suspected.There is no indication that there is a defective lot or that this event represents an emerging adverse quality trend.The root cause could not be reliably determined.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: sharon murphy ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 6941274
• MDR Text Key: 90105665
• Report Number: 9615742-2017-05509
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521190511
• UDI-Public: 10884521190511
• 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: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2021
• Device Model Number: SYM3020
• Device Catalogue Number: SYM3020
• Device Lot Number: PQG1177X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/31/2017
• Date Device Manufactured: 08/13/2016
• 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
• Patient Age: 45 YR