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

Model Number	DXT1612AR
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2022
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, during a laparoscopic bilateral inguinal hernia repair procedure, while implanting the mesh, the mesh did not align properly with the anatomy of the patient because of the anatomical properties of the mesh.This caused the inferior portion of the mesh to not lay properly.The surgeon also stated that the mesh did not give enough medical coverage for the surgeon to feel comfortable leaving the mesh in place.The surgeon decided to use a different mesh to complete the case and resolve the issue.There was no patient injury.
Additional Manufacturer Narrative
Additional information: b5, g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The involved device was not returned.However, 14 videos were provided.Visual inspection noted the mesh didn't cover the entire defect.It should be noted that no information on the defect size was provided.In addition the mesh involved was found as expected and showed no deficiency.It was reported that the mesh was difficult to adhere, did not stay in place, or shifted within the patient while being implanted.The reported issue was confirmed.The most likely cause could not be established from the information available.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.A secondary review of the device history records found no potentially contributing factors.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during a laparoscopic bilateral inguinal hernia repair procedure, while implanting the mesh, the mesh did not align properly with the anatomy of the patient because of the anatomical properties of the mesh.This caused the inferior portion of the mesh to not lay properly.The surgeon also stated that the mesh did not give enough medical coverage for the surgeon to feel comfortable leaving the mesh in place.The mesh was grasped with a grasper at the edge and pulled through.The surgeon decided to use a different mesh to complete the case and resolve the issue.There was no patient injury.

• Brand Name: DEXTILE
• Common Device Name: 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: tracy landers ; 5920 longbow drive; boulder, CO 80301 ; 3035816943
• MDR Report Key: 14215606
• Report Number: 9615742-2022-00371
• Device Sequence Number: 14792101
• Product Code: FTL
• UDI-Device Identifier: 10884521726536
• UDI-Public: 10884521726536
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K192443
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2022

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: 05/31/2026
• Device Model Number: DXT1612AR
• Device Catalogue Number: DXT1612AR
• Device Lot Number: SVF0517X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2022
• Supplement Date Received by Manufacturer: 07/20/2022
• Initial Report FDA Received Date: 04/26/2022
• Supplement Report FDA Received Date: 07/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/10/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 35 YR
• Patient Sex: Male