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

Catalog Number 1190500

Device Problem Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/02/2018

Event Type  malfunction  

Manufacturer Narrative

The sample evaluation of the returned mesh confirms for the reported condition of torn mesh.The mesh had been tailored by the user to create an l shape.In the corner of the l shape there is a tear where two edges were created when tailoring the mesh.This appears to be where the surgeon attempted to place a suture.There is no evidence of suture material left on the mesh, but it appears likely that the suture pulled out of the mesh as reported causing the damage noted.It is unknown if creating this l shape caused damaged to the mesh at the angle of the l before the user attempted to place the suture.The mesh is stretched in the area of the tear further indicating a pull force was applied to this area of the mesh.Visual examination of the mesh under magnification found no manufacturing anomalies with the material.It appears that the damage was related to force applied to the mesh and not due to material condition.Based on the available information and product evaluation it can be reasonably determined that forces applied to the mesh during attempted fixation caused the issue that presented.To date this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in (b)(6) 2017.A review of the manufacturing records was performed.No manufacturing issues associated to the reported event were found in the reviewed lot.Dhr review showed component acceptability and traceability were confirmed.All process steps were completed per manufacturing and inspection procedures.Product passed all required inspections at both end product and subassembly levels.There was no rework or other manufacturing abnormalities that may have contributed to this complaint.The information provided by bard 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 bard.

Event Description

It was reported that on (b)(6) 2018 during a "diep flap" (breast reconstruction) procedure while attempting to fixate a customized bd surgery / davol phasix mesh, the surgeon used a 0-maxon suture on a tapered needle and placed the suture about 1 cm from the mesh edge which reportedly would not hold the suture and tore the mesh.The phasix mesh was removed and the surgeon used an unspecified monofilament polypropylene flat mesh to complete the case.As reported, there was no patient injury or harm.

• Brand Name: PHASIX MESH
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 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: laura sundberg ; 100 crossings blvd.; warwick, RI 02886 ; 4018258462
• MDR Report Key: 7534594
• MDR Text Key: 109010579
• Report Number: 1213643-2018-01627
• Device Sequence Number: 1
• Product Code: OOD
• UDI-Device Identifier: 00801741077708
• UDI-Public: (01)00801741077708
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142818
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2019
• Device Catalogue Number: 1190500
• Device Lot Number: HUBW0165
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/27/2017
• 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 Age: 57 YR
• Patient Weight: 66