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

Catalog Number	0117070
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, the perfix light plug inner petal detached during implant.The subject device was returned for evaluation.Visual evaluation of the sample identified multiple tears in the inner plugs with one petal arm almost completely detaching and one petal arm completely detached.No damage was noted to the monofilament holding the petals together.A blue suture placed by the user during the attempted mesh placement had been cut, which likely led to damage to the inner petals.The outer large shell had an area of stretching and flattening, consistent with pulling on the mesh with a surgical tool such as graspers.Based on the sample evaluation and investigation performed, the reported event had inadvertently occurred most likely during user/device interface while in preparation to deploy the mesh.Review of manufacturing records indicate product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of 526 units released for distribution in december 2019.
Event or Problem Description
As reported, during an unspecified procedure on (b)(6) 2020, the physician tried to implant the perfix light plug, large into the patient's body.The physician noted that the inner petal was detached while inserting into the patient and the mesh was not implanted.The surgeon is an existing user of the device.There was no reported patient injury.

• Brand Name: PERFIX PLUG LIGHT
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 10874733
• Report Number: 1213643-2020-20052
• Device Sequence Number: 3766376
• Product Code: FTL
• UDI-Device Identifier: 00801741030963
• UDI-Public: (01)00801741030963
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K092032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/19/2020

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: 10/28/2024
• Device Catalogue Number: 0117070
• Device Lot Number: HUDX2606
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/12/2020
• Initial Report FDA Received Date: 11/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other