MAUDE Adverse Event Report: BARD SHANNON LIMITED -3005636544 3DMAX; SURGICAL MESH

Catalog Number	0115322
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, during insertion through an 8mm sized trocar, the extra-large 3dmax mesh tore.The subject device was returned for evaluation.Evaluation of the sample finds multiple tears in the edge seal from handling.A larger tear had resulted in a portion of the edge seal tearing away from the mesh.The mesh fibers at this location have been stretched and/or pulled, which is an indication this portion of the device saw increased forces when attempting to deploy with the 8mm trocar during placement.No manufacturing anomalies were found.Based on the sample evaluation and investigation performed, the root cause is determined to be user/device interface while handling the mesh and gripping during attempted deployment down an 8mm trocar.Review of manufacturing records indicate product was manufactured to specification, with no indication of a manufacturing related cause for the event reported.To date, this is the only reported complaint for this manufacturing lot of 193 units released for distribution in april, 2019.The precautions section of the instructions-for-use supplied with the device states.¿it is recommended to use a 10mm internal diameter trocar to introduce a medium bard 3dmax mesh, and an 11mm internal diameter trocar to introduce a large 3dmax mesh.The size of the extra-large bard 3dmax mesh may inhibit deployment through a trocar.Use an appropriate sized trocar to allow mesh to slide down the trocar with minimal force.If mesh will not easily deploy down the trocar, remove trocar and insert mesh through incision.Reinsert trocar.¿ sample evaluated.
Event or Problem Description
As reported, during a robotic inguinal hernia repair, on (b)(6) 2021 an extra-large bard/davol 3dmax mesh tore during insertion when the surgeon attempted to insert the mesh through an 8 mm laparoscopic port.A new package was opened to complete the case.There was no injury to the patient.

• Brand Name: 3DMAX
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): BARD SHANNON LIMITED -3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• MDR Report Key: 11934753
• Report Number: 1213643-2021-20137
• Device Sequence Number: 19922543
• Product Code: FTL
• UDI-Device Identifier: 00801741030772
• UDI-Public: (01)00801741030772
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K081010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/19/2021

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: 02/28/2024
• Device Catalogue Number: 0115322
• Device Lot Number: HUDQ0602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/17/2021
• Initial Report FDA Received Date: 06/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other