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

Catalog Number 0112680

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/24/2022

Event Type  malfunction  

Event Description

As reported, during an open inguinal hernia repair procedure on (b)(6) 2022, the bard flat mesh tore while suturing.It was reported that the surgeon tailored and customized the mesh prior to fixation.As reported, the surgeon has not changed his technique.There was no reported patient injury.

Manufacturer Narrative

As reported, the bard flat mesh tore during fixation.A photo was provided and review of the photo finds the mesh had been tailored for use.The subject device has been returned for evaluation and the evaluation is anticipated but not get begun.When the sample evaluation has been completed, a supplemental mdr will be submitted to report the results of sample evaluation.At this time, no conclusions can be made.Review of manufacturing records confirms product was manufactured to specification.To date, this is the only reported complaint from this manufacturing lot of (b)(4) units released for distribution in september, 2021.Regarding tailoring of the mesh the instructions-for-use, supplied with the device state, intact bard mesh exhibits high burst and tensile strength.However, when custom tailoring, in special circumstances where excessive force is placed on the mesh, the following guidelines may be helpful: when cutting a notch in the mesh, a v-shape with a radiused point will withstand more force than a v-shape which comes to a sharp point.

Manufacturer Narrative

As reported, the bard flat mesh tore during fixation.A photo was provided and review of the photo finds the mesh had been tailored for use.The subject device has been returned for evaluation and the evaluation is anticipated but not get begun.When the sample evaluation has been completed, a supplemental mdr will be submitted to report the results of sample evaluation.At this time, no conclusions can be made.Review of manufacturing records confirms product was manufactured to specification.To date, this is the only reported complaint from this manufacturing lot of 1,023 units released for distribution in september, 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 returned sample confirms the reported event.The user tailored the mesh cutting from the edges inward.The pulling of the mesh caused the areas to unravel from forces applied and stress on the product while in use.The user also created two supporting tails that have areas unraveling.It is unknown how much force the surgeon applied to the mesh while performing the ¿integrity test.¿ no manufacturing anomalies were found.Based on the sample evaluation and investigation performed, the root cause for the torn mesh condition is determined to be consistent with the forces applied in use.Regarding tailoring of the mesh, the instructions-for-use supplied with the device state, "intact bard mesh exhibits high burst and tensile strength.However, when custom tailoring, in special circumstances where excessive force is placed on the mesh, the following guidelines may be helpful: when cutting a notch in the mesh, a v-shape with a radiused point will withstand more force than a v-shape which comes to a sharp point." 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 Description

As reported, during an open inguinal hernia repair procedure on 24-mar-2022, the bard flat mesh tore while suturing.It was reported that the surgeon tailored and customized the mesh prior to fixation.As reported, the surgeon has not changed his technique.There was no reported patient injury.

• Brand Name: BARD FLAT MESH
• Type of Device: 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: 14140773
• MDR Text Key: 289504560
• Report Number: 1213643-2022-00160
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741016530
• UDI-Public: (01)00801741016530
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0112680
• Device Lot Number: HUFV1853
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2022
• Date Manufacturer Received: 04/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other