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

Catalog Number	0117322
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported the mesh tore while preparing for use.Review of photos provided shows multiple tears in the edges of the mesh, and it appears that one portion of the edge seal is detached.Based on the photo and information provided root cause would appear to be the result of forces applied to the mesh while handling and folding the mesh in preparation for use.To date, this is the only reported complaint for this manufacturing lot.
Event or Problem Description
As reported, during a bilateral laparoscopic inguinal surgery on 12-dec-2022, while folding the right-sided 3dmax light mesh in preparation for insertion, multiple edges of the mesh tore.It was reported that another 3dmax light mesh was used to complete the right sided repair.There was no reported patient injury.
Event or Problem Description
As reported, during a bilateral laparoscopic inguinal surgery on (b)(6) 2022, while folding the right-sided 3dmax light mesh in preparation for insertion, multiple edges of the mesh tore.It was reported that another 3dmax light mesh was used to complete the right sided repair.There was no reported patient injury.
Additional Manufacturer Narrative
As reported the mesh tore while preparing for use.Review of photos provided shows multiple tears in the edges of the mesh, and it appears that one portion of the edge seal is detached.Based on the photo and information provided root cause would appear to be the result of forces applied to the mesh while handling and folding the mesh in preparation for use.To date, this is the only reported complaint for this manufacturing lot.Addendum: this is an addendum to the initial mdr submitted.This supplemental mdr is submitted to report the results of the sample evaluation.The subject device was returned for evaluation.Visual evaluation of the sample finds there are multiple tears in the edge seal as result of forces / handling of the mesh while folding for insertion into the trocar as reported.There is one section of the edge seal that has torn away from the mesh.Based on the investigation performed and sample evaluation, the root cause determined to be user/device interface while handling and folding the mesh with while attempting to deploy.No manufacturing anomalies were found.Review of manufacturing records confirms product was manufactured to specification, with no indication of a manufacturing related cause for the event reported.To date, this is the only reported complaint for this manufacturing lot of (b)(4) released for distribution in mar, 2022 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: 16091520
• Report Number: 1213643-2022-00829
• Device Sequence Number: 11267536
• Product Code: FTL
• UDI-Device Identifier: 00801741031076
• UDI-Public: (01)00801741031076
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K091659
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2023

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: 0117322
• Device Lot Number: HUGN0671
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/12/2022
• Supplement Date Received by Manufacturer: 01/04/2023
• Initial Report FDA Received Date: 01/03/2023
• Supplement Report FDA Received Date: 01/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/07/2022
• 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 Age: 60 YR
• Patient Sex: Male