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

Model Number	PP1208DL
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/19/2019
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 fixation of the mesh on an open inguinal left repair procedure, when the surgeon put the suture through the mesh, it broke at the junction of the flap.Another mesh was used 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.Especially, the records related to the mechanical testing of the textile batch and the zig zag stitching of flap on the mesh were found within qa specifications.The visual examination of the returned sample shows that: the sample was not returned in its original packaging and placed in a biohazard bag.The mesh was found not contaminated by blood.The textile knitting pattern and the left size were found as expected.The sample was found cut in 5 parts.The flap and the mesh were detached.The green yarn is visible on the mesh.The slit was found frayed.The yarn of zig zag stitching of flap on mesh is not visible.It should be noted that the event description sates that ¿when the surgeon put the suture through the mesh¿.The visual examination showed that the mesh was found cut in 5 separated pieces and was not contaminated by blood.No information regarding the patient condition, the defect size and the mesh manipulation were provided.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.Conclusion of the visual examination: due to the condition of the mesh returned (redrawn), the reported condition could not be confirmed.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.

• Brand Name: PROGRIP
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): SOFRADIM PRODUCTION SAS; 116 avenue du formans; trevoux 01600 ; FR 01600
• MDR Report Key: 9432840
• Report Number: 9615742-2019-03817
• Device Sequence Number: 14098106
• Product Code: FTL
• UDI-Device Identifier: 10884521177659
• UDI-Public: 10884521177659
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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): 03/30/2020

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: 06/30/2024
• Device Model Number: PP1208DL
• Device Catalogue Number: PP1208DL
• Device Lot Number: STG2037X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2020
• Initial Date Received by Manufacturer: 11/19/2019
• Supplement Date Received by Manufacturer: 03/27/2020
• Initial Report FDA Received Date: 12/06/2019
• Supplement Report FDA Received Date: 03/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR