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

Catalog Number	0115322
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2021
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during an laparoscopic inguinal hernia repair/tepp procedure on (b)(6) 2021, the bard/davol 3dmax mesh (right x-large) was inserted through a 10mm trocar, the mesh tore.The surgeon removed the mesh out of the trocar and used a new mesh to complete the case.There was no reported patient injury.
Additional Manufacturer Narrative
As reported, during insertion of an x-large 3dmax mesh through a 10mm trocar, the mesh tore.It is reported that the subject device is being returned for evaluation; however at this time it has not been received.Based on the information provided the root cause is most probably due the use of a 10mm trocar with an x-large sized 3dmax mesh.However, without having the sample to evaluate, no definitive conclusion can be made.Per the instructions-for-use (ifu), supplied with the device, ¿it is recommended to use a 10mm internal diameter trocar to introduce a medium bard 3dmax mesh, and an 11mm internal diameter trocar to introduce a large bard 3dmax mesh.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.A review of the manufacturing records found the lot was manufactured to specification.To date, this is the only complaint reported for this manufacturing lot of (b)(4) units released for distribution in june, 2021.If/when the sample is returned and evaluated and/or additional information is provided, a supplemental mdr will be submitted.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.Not returned.
Event or Problem Description
As reported, during a laparoscopic inguinal hernia repair/tepp procedure on (b)(6) 2021, when the bard/davol 3dmax mesh (right x-large) was inserted through a 10mm trocar, the mesh tore.The surgeon removed the mesh out of the trocar and used a new mesh to complete the case.There was no reported patient injury.
Additional Manufacturer Narrative
As reported, during insertion of an x-large 3dmax mesh through a 10mm trocar, the mesh tore.It is reported that the subject device is being returned for evaluation; however at this time it has not been received.Based on the information provided the root cause is most probably due the use of a 10mm trocar with an x-large sized 3dmax mesh.However, without having the sample to evaluate, no definitive conclusion can be made.A review of the manufacturing records found the lot was manufactured to specification.To date, this is the only complaint reported for this manufacturing lot of (b)(4) units released for distribution in june, 2021.Addendum: this is an addendum to the initial mdr submitted.This supplemental mdr is submitted to report the results of the sample evaluation.Visual evaluation of the sample finds multiple tears in the edge seal, going into the mesh.No manufacturing anomalies were found.Based on the sample evaluation and investigation performed, the root cause for the issue that presented is determined to be user/device interface while inserting / deploying the extra-large size mesh through the 10mm trocar.Per the instructions-for-use (ifu) supplied with the device, ¿it is recommended to use a 10mm internal diameter trocar to introduce a medium bard 3dmax mesh, and an 11mm internal diameter trocar to introduce a large bard 3dmax mesh.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.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.H3 other text : sample evaluated.

• 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: 13025271
• Report Number: 1213643-2021-20472
• Device Sequence Number: 4926477
• Product Code: FTL
• UDI-Device Identifier: 00801741030772
• UDI-Public: (01)00801741030772
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K081010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2022

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: 0115322
• Device Lot Number: HUFS0331
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2022
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/02/2021
• Supplement Date Received by Manufacturer: 01/04/2022
• Initial Report FDA Received Date: 12/17/2021
• Supplement Report FDA Received Date: 01/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/21/2021
• 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