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

Catalog Number	0117321
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, a robotic procedure was performed using an 8mm metal cannula (trocar).During the procedure, a part of the 3dmax light mesh tore while deploying down the trocar.A second mesh was successfully implanted without any issues.There was no patient injury.
Additional Manufacturer Narrative
As reported, a part the 3dmax light mesh was torn while deploying down an 8mm trocar.The physical sample is said to be available for evaluation; however, at this time it has not been received.Based on the information available and without having the sample to evaluate, no conclusions can be made.A review of the manufacturing records was performed and found the lot was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units.If/when the sample is returned and evaluated a supplemental mdr will be submitted to document the results.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, a robotic procedure was performed using an 8mm metal cannula (trocar).During the procedure, a part of the 3dmax light mesh tore while deploying down the trocar.A second mesh was successfully implanted without any issues.There was no patient injury.
Additional Manufacturer Narrative
As reported, a part the 3dmax light mesh was torn while deploying down an 8mm trocar.The physical sample is said to be available for evaluation; however, at this time it has not been received.Based on the information available and without having the sample to evaluate, no conclusions can be made.A review of the manufacturing records was performed and found the lot was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of 1,426 units.If/when the sample is returned and evaluated a supplemental mdr will be submitted to document the results.Addendum: this supplemental mdr is submitted to document the sample evaluation results.Evaluation of the sample finds there is a tear in the edge seal of the mesh.The tear starts at the seal and continues along the seal edge, separating the seal from the mesh completely.The detached piece of seal edge was returned.A tear of this nature would not be an out of the box condition and can present with forces applied to mesh.Based on the event as reported and sample condition, the likely root cause is inadvertent damage while deploying through the trocar in use.No manufacturing anomalies were found.The precautions section in the instructions-for-use, supplied with the device states, "use an appropriately sized trocar to allow mesh to slide down the trocar with minimal force." 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.

• 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: 23425904
• Report Number: 1213643-2025-01042
• Device Sequence Number: 9626476
• Product Code: FTL
• UDI-Device Identifier: 00801741031069
• UDI-Public: (01)00801741031069(11)250221(17)300128(10)HUKP1469
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K091659
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2025

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: 0117321
• Device Lot Number: HUKP1469
• 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: 10/10/2025
• Supplement Date Received by Manufacturer: 12/08/2025
• Initial Report FDA Received Date: 10/30/2025
• Supplement Report FDA Received Date: 12/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2025
• 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