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

Catalog Number	0116321
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, a 3dmax mid mesh was noted to be cracked (tear).Based on the review of photo provided, there was a small tear in the sealed edge of the mesh.The subject device is being returned for evaluation.When the sample evaluation is completed, a supplemental mdr will be submitted.Review of manufacturing records shows product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of 1098 units released for distribution in september 2023.Note: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
As reported, during a da vinci inguinal hernia repair, while opening the 3dmax mid right mesh it was noted that the bottom portion of the mesh was cracked.It was reported that the surgeon did not use the mesh.There was no patient injury.
Additional Manufacturer Narrative
As reported, a 3dmax mid mesh was noted to be cracked (tear).Based on the review of photo provided, there was a small tear in the sealed edge of the mesh.The subject device is being returned for evaluation.When the sample evaluation is completed, a supplemental mdr will be submitted.Review of manufacturing records shows product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in september 2023.Addendum: this supplemental mdr is submitted to document the results of sample evaluation.Evaluation of the returned sample finds that there are two small cracks in the edge seal of the mesh and the condition of the mesh is consistent with that of a mesh that had been rolled or folded and attempted to be implanted.No manufacturing anomalies were found.Based on sample evaluation the root cause is the edge seal was inadvertently damaged/torn during attempted use.The instructions-for-use supplied with the device, states "it is recommended to use 8 mm or larger internal diameter trocar to introduce 3dmax mid anatomical mesh.¿ updated fields: a3, b4, d9, g3, g6, h2, h3, h6, h10.Note: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
As reported, during a da vinci inguinal hernia repair, while opening the 3dmax mid right mesh it was noted that the bottom portion of the mesh was cracked.It was reported that the surgeon did not use the mesh.There was no 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: 20569260
• Report Number: 1213643-2024-00518
• Device Sequence Number: 18096901
• Product Code: FTL
• UDI-Device Identifier: 00801741200786
• UDI-Public: (01)00801741200786(17)280728(10)HUHV0724
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2024

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: 0116321
• Device Lot Number: HUHV0724
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2024
• Supplement Date Received by Manufacturer: 10/30/2024
• Initial Report FDA Received Date: 10/30/2024
• Supplement Report FDA Received Date: 11/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/13/2023
• 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: Male