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

Catalog Number 0117311

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/26/2021

Event Type  malfunction  

Manufacturer Narrative

As reported, during insertion through a port the 3dmax light mesh was damaged and ripped.The subject device was returned for evaluation.Evaluation of the sample finds that there are multiple frays/tearing in the edge seal of the mesh, with portions detached.This was not reported as an out of box condition and the found tearing condition is not indicative of the as manufactured condition.No manufacturing anomalies were found.Based on the sample evaluation and investigation performed, root cause is the result of handling and inadvertently occurred during user/device interface while deploying the mesh through the port.The precautions section of the instruction for use supplied with this device states, "use an appropriate sized trocar to allow mesh to slide down the trocar with minimal force." review of manufacturing records confirms product was manufactured to specification, with no indication of a manufacturing related cause for the event reported.To date, this is the only complaint reported for this manufacturing lot of (b)(4) units released for distribution in (b)(6) 2021.Note, the date of event is considered to be a best estimate as (b)(6) 2021 based on the date of awareness.

Event Description

As reported, during a laparoscopic inguinal hernia repair surgery, while implanting bard/davol 3dmax light mesh into the abdomen through a port, the mesh was damaged and ripped.As reported, 5mm trocar was used on the case, however the reporter was not sure that the mesh was introduced through this trocar.Another 3dmax mesh was used to complete the case.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: 12333264
• MDR Text Key: 266962083
• Report Number: 1213643-2021-20257
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741031038
• UDI-Public: (01)00801741031038
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091659
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0117311
• Device Lot Number: HUEX1411
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2021
• Date Manufacturer Received: 07/26/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/11/2021
• 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