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

Model Number	SYM15F
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/25/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, when spreading the mesh during a laparoscopic intraperitoneal onlay mesh, the mesh broke when placed in the abdominal wall and there was an unanticipated tissue loss.A new mesh was taken to complete the case.There was no patient injury.
Additional Manufacturer Narrative
Evaluation summary: one device was returned for investigation.A review of the device history record has been performed and no failure that may relate to the reported conditions have been noted.The visual examination of the returned sample shows that: the sample was returned in its original commercial box and tray.The mesh was found contaminated by blood.The textile knitting pattern, the collagen film and the mesh dimension were found as expected.One blue yarn has been added prior use.The mesh was folded in multiple parts collagen outside.The mesh maintains its folded position.The textile frays on around 4 x 4 stitches, located on one of the main folds.The reported condition was partially confirmed.The mesh was not broken but the textile was slightly damaged.The product instructions for use (ifu) which accompanies each device states in chapter ¿operating steps¿ that ¿4.Should it be used in a laparoscopic approach, symbotex¿ composite mesh is to be rolled after hydration, with the film facing the inside.The film is then protected when inserted in the trocar¿.The visual examination of the provided sample shows that the mesh was folded collagen outside.Based on the available information, 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 determined.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SYMBOTEX
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): SOFRADIM PRODUCTION SAS; 116 avenue du formans; trevoux 01600 ; FR 01600
• MDR Report Key: 7768809
• Report Number: 9615742-2018-01863
• Device Sequence Number: 2062093
• Product Code: FTL
• UDI-Device Identifier: 10884521190405
• UDI-Public: 10884521190405
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K131969
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: SYM15F
• Device Catalogue Number: SYM15F
• Device Lot Number: PRK0248X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2018
• Initial Date Received by Manufacturer: 07/25/2018
• Supplement Date Received by Manufacturer: 11/21/2018
• Initial Report FDA Received Date: 08/09/2018
• Supplement Report FDA Received Date: 12/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Weight: 100