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

Catalog Number	0117170
Medical Device Problem Codes	Material Frayed (1262); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/28/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This initial mdr is being submitted as a result of a retrospective review of davol¿s mdr decisions and the initial decision not to report the event is being revised to reflect updated company procedures.The onlay portion of the device was returned for evaluation and is confirmed for fraying and deformation of the mesh.As stated this was not an out of the box condition.The sample was received in a contaminated state with a suture present indicating that there was an attempt made to implant the onlay mesh.Visual evaluation confirms the user cut the mesh in attempt to make a keyhole in the onlay.It appears that during attempted implantation of the onlay, fraying and deformation of the mesh occurred due to forces applied on one of the inner cut edges made by the user to create the key hole.Root cause for the noted damage to the onlay is user/device interface.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 or Problem Description
Contact alleged that the surgeon was trimming the onlay portion of the plug and patch and the material frayed.Surgeon used another of the same to complete the case without issue.There was no patient impact.

• Brand Name: PERFIX LIGHT PLUG
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 6745717
• Report Number: 1213643-2017-00456
• Device Sequence Number: 771632
• Product Code: FTL
• UDI-Device Identifier: 00801741031007
• UDI-Public: (01)00801741031007(17)201028(10)HUZK0131
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K092032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/26/2017

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 Expiration Date: 10/28/2020
• Device Catalogue Number: 0117170
• Device Lot Number: HUZK0131
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2016
• Initial Report FDA Received Date: 07/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1