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

Catalog Number	0115311
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, during the procedure, while inserting the 3dmax mesh through a trocar, the mesh tore.Based on the information available and without having the sample to evaluate, no definitive conclusions can be made.Although a conclusive root cause could not be determined, this event was not reported as an out of box issue.It is possible that the issue presented due to user/device interface during insertion of the mesh through the trocar.A review of the manufacturing records was performed and found that the lot was manufactured to the specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units.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 procedure on (b)(6) 2026, while inserting the 3dmax mesh through a trocar, the mesh tore.The procedure was completed using a new mesh, which resulted in a longer operation time.There was no patient harm or injury.
Additional Manufacturer Narrative
As reported, during the procedure, while inserting the 3dmax mesh through a trocar, the mesh tore.Based on the information available and without having the sample to evaluate, no definitive conclusions can be made.Although a conclusive root cause could not be determined, this event was not reported as an out of box issue.It is possible that the issue presented due to user/device interface during insertion of the mesh through the trocar.A review of the manufacturing records was performed and found that the lot was manufactured to the specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units.Addendum: this is an addendum to the initial mdr submitted to document the sample evaluation results.The evaluation of the sample confirms that there is a tear present in the edge seal of the mesh near the medial marker.The tear starts at the seal and continues into the mesh.A tear of this nature would not be an out of the box condition and can present with forces applied to mesh during use.Based on the event as reported and sample condition, the most likely root cause is inadvertent damage while deploying through the trocar in use.No manufacturing anomalies were found.Updated fields: 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 procedure on (b)(6) 2026, while inserting the 3dmax mesh through a trocar, the mesh tore.The procedure was completed using a new mesh, which resulted in a longer operation time.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: 24595648
• Report Number: 1213643-2026-00334
• Device Sequence Number: 8697792
• Product Code: FTL
• UDI-Device Identifier: 00801741030734
• UDI-Public: (01)00801741030734(11)250512(17)300428(10)HUKS0193
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K081010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2026

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: 0115311
• Device Lot Number: HUKS0193
• 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: 02/24/2026
• Supplement Date Received by Manufacturer: 04/09/2026
• Initial Report FDA Received Date: 03/13/2026
• Supplement Report FDA Received Date: 04/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/12/2025
• 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