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

Catalog Number	0117320
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/04/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 11251668
• Report Number: 1213643-2021-20012
• Device Sequence Number: 11658385
• Product Code: FTL
• UDI-Device Identifier: 00801741031052
• UDI-Public: (01)00801741031052
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K091659
• 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
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 01/28/2025
• Device Catalogue Number: 0117320
• Device Lot Number: HUEN1850
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/05/2021
• Initial Report FDA Received Date: 01/29/2021
• 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