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

Catalog Number	0116322
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned sample finds there are multiple tears in the edge seal and shows signs of being folded or rolled.There is one section where a tear at the edge seal travels into the mesh monofilament.This is a result of the mesh likely being pulled on / handled with force at this location which is indicated by the contamination found at this location.Based on the event as reported and sample condition found, the root cause is user/device interface while prepping the mesh for use.No manufacturing anomalies were found.Review of manufacturing records shows product was made to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in august 2022.Sample evaluated.
Event or Problem Description
As reported the customer was using the 3d max mid mesh and when they rolled it around the trocar for insertion it cracked along the inferior edge of the mesh.In follow up it was reported that, during a robotic right femoral hernia repair, upon opening the package of 3dmax mid mesh, the edge of the mesh was noted to be cracked.It was reported that the mesh was never rolled or inserted into the trocar.As reported a new 3dmax mid mesh was used for the case without any further issues.There was no reported patient injury.

• Brand Name: 3DMAX MID
• 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: 16522721
• Report Number: 1213643-2023-00083
• Device Sequence Number: 14057248
• Product Code: FTL
• UDI-Device Identifier: 00801741200793
• UDI-Public: (01)00801741200793
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K200818
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/23/2023

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: 0116322
• Device Lot Number: HUGTAB17
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/17/2023
• Initial Report FDA Received Date: 03/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/05/2022
• 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