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

Catalog Number	0116311
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, the edges of the 3dmax mid were noted be cracked.The subject device has been discarded.The photo evaluation shows what appears to be a crack in the bottom edge seal on the medial marker side.As the physical sample was not returned for evaluation a definitive root cause cannot be determined.However, based on the event as reported the most probable root cause of the crack/tearing of the edge seal is forces applied during use.The precautions section of the instructions-for-use states, "use an appropriate sized trocar to allow mesh to slide down the trocar with minimal force.¿ a review of the manufacturing records was performed and found that the lot was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of 907 units released for distribution in august 2023.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, the edges of the 3dmax mid were noted be cracked.An 8mm trocar was used for the procedure.It was reported that the surgeon opened another piece of mesh to complete the procedure.There was no patient injury.In follow up with the sales rep, who was not present in this case, it was stated the or staff are ¿kind of rough with handling the mesh when removing from the packaging and inserting it through the trocar.".

• 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: 18885724
• Report Number: 1213643-2024-00083
• Device Sequence Number: 3089476
• Product Code: FTL
• UDI-Device Identifier: 00801741200755
• UDI-Public: (01)00801741200755
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Report Date (Section B): 02/26/2024

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: HUHU0575
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2024
• Initial Report FDA Received Date: 03/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2023
• 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