MAUDE Adverse Event Report: SOFRADIM PRODUCTION SYMBOTEX COMPOSITE MESH/ 8CM DIAMETER; MESH, SURGICAL, POLYMERIC

Model Number SYM8OS

Device Problem Material Separation (1562)

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

Event Date 03/16/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The product was not returned for investigation.A visual examination of the provided photo shows that the surgical procedure was performed in an open approach.A piece of green textile seemed to be separated from the white textile.The white textile is visible at the bottom of the incision.The device was not cut prior to implantation.A review of the device history record (dhr) has been performed.This review confirmed that this lot of products was reviewed and released according to quality specifications, including records related to the mechanical testing of the monofilament yarns used to manufacture the device.A review of the manufacturing records related to stitching and whipping also indicate that the device met quality specifications.Each device is manually casted, cut, packaged and visually inspected prior to release.With limited information available and no physical sample to evaluate, a definitive root cause could not be determined.Should additional information become available, the record will be re-evaluated and amended as needed.

Event Description

According to the reporter, the patient underwent an open abdominal wall hernia repair.It was stated that, when the surgeon attempted to fire from an anterior approach to set the mesh, part of the green textile had detached from the mesh.The subject part was reinforced with a hand stitch.The defect was located in the bottom right portion of the mesh.The mesh was not cut or manipulated prior to implantation.There was no adverse event to the patient and the patient was doing well post-operation.

• Brand Name: SYMBOTEX COMPOSITE MESH/ 8CM DIAMETER
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): SOFRADIM PRODUCTION; 116 avenue du formans; trevoux ; FR
• Manufacturer (Section G): SOFRADIM PRODUCTION; 116 avenue du formans; trevoux ; FR
• Manufacturer Contact: sharon murphy ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 5583910
• MDR Text Key: 42853874
• Report Number: 9615742-2016-00018
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K131969
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2019
• Device Model Number: SYM8OS
• Device Catalogue Number: SYM8OS
• Device Lot Number: POH0253X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1