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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, while positioning to fixate the 3dmax light mesh with graspers the mesh ripped into two pieces.Evaluation of the returned sample finds visible tearing in the edge seal of the mesh and a piece near the medial marker has torn off.The torn piece has visible fraying and tool markings from the graspers indicating the mesh was grabbed and pulled.The found edge seal tearing condition is not indicative of the as manufactured condition.No manufacturing anomalies were found.Based on the event as reported and sample condition, the tearing most likely occurred inadvertently during user/device interface while positioning the mesh.The size trocar used during this laparoscopic procedure was not reported, per the precautions section of the instructions-for- use supplied with this device, "use an appropriate sized trocar to allow mesh to slide down the trocar with minimal force.".
Event or Problem Description
As reported, during laparoscopic inguinal hernia repair procedure on (b)(6) 2022, while positioning to fixate the bard/davol 3dmax light mesh using graspers, mesh ripped into two pieces.It was reported that the mesh was removed from patient's body and another 3dmax light mesh was used to complete the procedure.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
• 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: 15690033
• Report Number: 1213643-2022-00678
• Device Sequence Number: 17988040
• Product Code: FTL
• UDI-Device Identifier: 00801741031052
• UDI-Public: (01)00801741031052
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K091659
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/13/2022

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 Catalogue Number: 0117320
• Device Lot Number: HUGQ1308
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/06/2022
• Initial Report FDA Received Date: 10/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown