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

Catalog Number	0115312
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, the x-large 3dmax mesh ripped during insertion through a 12 mm laparoscopic port.The subject device was returned for evaluation.Initial evaluation finds multiple visible frays/tearing in the edge seal of the mesh.No manufacturing anomalies were found.Per the instructions for use (ifu), "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." based on the sample evaluation and investigation performed, the root cause is determined to be user/device interface while deploying the x-large mesh down the 12mm trocar.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 reported complaint for this manufacturing lot of (b)(4) units released for distribution in june, 2021.
Event or Problem Description
As reported, during a laparoscopic left inguinal hernia repair procedure on (b)(6) 2021, a x-large bard/davol 3dmax left mesh was inserted through a 12 mm trocar.Once the mesh was pushed through completely, it was noted that the mesh had torn along the edges.As reported, the mesh was removed from the patient and another x-large 3dmax mesh was used to complete the case.As reported, there was no patient harm or injury.

• Brand Name: 3DMAX
• 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: 12883915
• Report Number: 1213643-2021-20431
• Device Sequence Number: 17118551
• Product Code: FTL
• UDI-Device Identifier: 00801741030741
• UDI-Public: (01)00801741030741
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K081010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/11/2021

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: 04/28/2026
• Device Catalogue Number: 0115312
• Device Lot Number: HUFS0395
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/09/2021
• Initial Report FDA Received Date: 11/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/24/2021
• 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