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

Catalog Number	0116311
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
At this time, no conclusions can be made as review of the returned sample is currently ongoing.When the sample evaluation is completed, a supplemental mdr will be submitted.Review of manufacturing records confirms product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of 466 units released for distribution in february 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.
Event or Problem Description
As reported, during a robotic inguinal hernia repair, it was found that the 3dmax mid mesh was not woven properly in a certain spot causing a knot.As reported, the procedure was completed by using another 3dmax mid mesh.There was no reported patient injury.
Event or Problem Description
As reported, during a robotic inguinal hernia repair, it was found that the 3dmax mid mesh was not woven properly in a certain spot causing a knot.As reported, the procedure was completed by using another 3dmax mid mesh.There was no reported patient injury.
Additional Manufacturer Narrative
At this time, no conclusions can be made as review of the returned sample is currently ongoing.When the sample evaluation is completed, a supplemental mdr will be submitted.Review of manufacturing records confirms product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) released for distribution in february 2022.Addendum: this is an addendum to the initial mdr submitted, to document the sample evaluation results.Sample evaluation finds no visible contamination on the mesh.There are tears/frays noted in the edge seal of the mesh and the area in question of the reported "knot" is an area where the mesh weave has been stretched/pulled with no separation of the material.It was determined that, condition may have originated during knitting manufacturing process.Based on the sample evaluation and investigation performed, the root cause is determined to be a manufacturing generated condition.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 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: 16876885
• Report Number: 1213643-2023-00180
• Device Sequence Number: 5822492
• Product Code: FTL
• UDI-Device Identifier: 00801741200755
• UDI-Public: (01)00801741200755
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2023

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: 0116311
• Device Lot Number: HUFZAB13
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/12/2023
• Supplement Date Received by Manufacturer: 05/08/2023
• Initial Report FDA Received Date: 05/05/2023
• Supplement Report FDA Received Date: 05/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/16/2022
• 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 Sex: Unknown