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

Catalog Number	0116321
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during a robotic procedure, while rolling the 3dmax mid mesh in preparation to place through an 8mm trocar, the surgeon found cracking of the sealed edge of the device.It was reported that edge of the mesh was brittle and peeling off.It was reported that the same issue persisted in multiple devices.The procedure was completed with another 3dmax mid mesh which did not crack.There was no patient injury.
Additional Manufacturer Narrative
As reported, while preparing the 3dmax mid implant for insertion through cannula, the sealed edges cracked and tore when rolling it onto a grasper.This presented with multiple 3dmax mid units from different lots.A unit that did not tear in preparation was used to complete the case.There was no patient harm because of the problem experienced.The subject device for this 3dmax mid (lot huhn1064) was not returned for evaluation.Visual inspection of two samples (lot huhn1508 and lot huhn1513) returned by the user confirms the mesh is torn at the edge seal as reported.Dimensional inspection of the two returned units confirmed the edge seal was manufactured to specification.Review of manufacturing records (lot huhn1064) confirms the product was made to specification.Lot qty 949 units released for distribution in march 2023.No other complaints of this nature have been reported for this lot to date.The most probable root cause for the edge seals tearing in force applied to the 3dmax mid mesh while rolling the mesh onto the grasper.This mdr represents 3dmax mid (device #6).Additional mdr's were submitted to represents 3dmax mid (device #1, #2, #3, #4, #5, #7, #8 and #9).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 not returned.
Additional Manufacturer Narrative
As reported, while preparing the 3dmax mid implant for insertion through cannula, the sealed edges cracked and tore when rolling it onto a grasper.This presented with multiple 3dmax mid units from different lots.A unit that did not tear in preparation was used to complete the case.There was no patient harm because of the problem experienced.The subject device for this 3dmax mid (lot huhn1064) was not returned for evaluation.Visual inspection of two samples (lot huhn1508 and lot huhn1513) returned by the user confirms the mesh is torn at the edge seal as reported.Dimensional inspection of the two returned units confirmed the edge seal was manufactured to specification.Review of manufacturing records (lot huhn1064) confirms the product was made to specification.No other complaints of this nature have been reported for this lot to date.The most probable root cause for the edge seals tearing in force applied to the 3dmax mid mesh while rolling the mesh onto the grasper.Addendum: h11: this is an addendum to the initial mdr submitted to correct the distribution period in the manufacturer narrative which was inadvertently added incorrectly.Lot qty units 949 released for distribution in (b)(6) 2023.Updated fields: b4, e1, g3, g6, h2, h11 corrected field: h10 (manufacturer narrative) this mdr represents 3dmax mid (device #6).Additional mdr's were submitted to represents 3dmax mid (device #1, #2, #3, #4, #5, #7, #8 and #9) 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 not re0turned.
Event or Problem Description
As reported, during a robotic procedure, while rolling the 3dmax mid mesh in preparation to place through an 8mm trocar, the surgeon found cracking of the sealed edge of the device.It was reported that edge of the mesh was brittle and peeling off.It was reported that the same issue persisted in multiple devices.The procedure was completed with another 3dmax mid mesh which did not crack.There was no patient injury.

• 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: 17588757
• Report Number: 1213643-2023-00303
• Device Sequence Number: 2395201
• Product Code: FTL
• UDI-Device Identifier: 00801741200786
• UDI-Public: (01)00801741200786
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2023

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: 0116321
• Device Lot Number: HUHN1064
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/26/2023
• Supplement Date Received by Manufacturer: 08/31/2023
• Initial Report FDA Received Date: 08/21/2023
• Supplement Report FDA Received Date: 09/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/11/2023
• 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