MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 3DMAX LIGHT; SURGICAL MESH

Catalog Number 0117320

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/04/2021

Event Type  malfunction  

Manufacturer Narrative

As reported, during insertion, a small portion of the mesh edge was torn on the 3dmax light mesh.The subject device was returned for evaluation.Evaluation of the sample finds multiple tears in the edge seal from handling.There is a larger tear that results in the edge seal partially separating from the mesh fibers.This was not reported as an out of box condition.Based on the sample evaluation and investigation performed, the reported event was confirmed and the root cause is user/device interface while handling the mesh with instrumentation and inserting through the port (trocar).The size of the trocar used was unknown.The precautions section of the instructions for use (ifu) supplied with this device states "use an appropriate sized trocar to allow mesh to slide down the trocar with minimal force." a review of the manufacturing records was performed and found that the lot was manufactured to specification.To date, this is the only reported complaint from this manufacturing lot of (b)(4) units released for distribution in february 2020.

Event Description

As reported, during a laparoscopic inguinal hernia repair procedure on (b)(6) 2021, when the surgeon inserted the bard/davol 3dmax light mesh down the port, a small part of the edge of the mesh was torn.The surgeon removed the mesh and completed the procedure using another bard/davol 3dmax mesh and there was a delay of 2-3 minutes.As reported, the surgeon was not sure if the instrument used caused it or something in the port, but from the surgeon's perspective significant force was not applied.There was no reported patient injury.

• Brand Name: 3DMAX LIGHT
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 100 crossings blvd.; warwick RI 02886
• Manufacturer (Section G): BARD SHANNON LIMITED -3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 8005566756
• MDR Report Key: 11251668
• MDR Text Key: 229825968
• Report Number: 1213643-2021-20012
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741031052
• UDI-Public: (01)00801741031052
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K091659
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/08/2021

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
• Device Operator: Health Professional
• Device Catalogue Number: 0117320
• Device Lot Number: HUEN1850
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/05/2021
• Initial Date FDA Received: 01/29/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other