MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 PERMAFIX ENHANCED; STAPLE, IMPLANTABLE

Catalog Number	0113120
Medical Device Problem Codes	Mechanical Problem (1384); Failure to Form Staple (2579)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during a ventral hernia repair procedure on (b)(6) 2022, the patient was implanted with an unknown mesh fixated using a bard/davol permafix fixation device.As reported, counter pressure was applied on the target area while fixating the implant into the tissue and the handle (trigger) was able to be pulled completely.It was reported that the fastener has no firing force and the mesh cannot be fixated into the tissue.It was reported that fasteners were loose and removed from the patient body.There was no reported patient injury.
Additional Manufacturer Narrative
As reported, the permafix fixation device didn't fixate the mesh.There was no reported patient injury.At this time the sample has not been provided for review.A video of the device was provided and evaluated.Review of the video provided shows an unknown user actuating the device outside of an or setting onto a table top.The user is slowly pulling on the trigger and deploying a fastener with no issue.However, during the dry deployment it was shown that the user was not using a complete and continuous stroke in the video to deploy as per the ifu.Based on the information provided and investigation performed, the root cause of the reported event cannot be determined.The instructions-for-use (ifu) for the permafix fixation device prescribes the proper method for use of this device for proper fastener delivery and includes "place the tip of the permafix fixation system at the desired location perpendicular (90 degree angle) to the mesh or tissue and apply adequate pressure.Different types of mesh may require different amounts of counterpressure.Adjust angle and counterpressure appropriately." if/when sample is received and evaluated, a supplemental mdr will be submitted.Note, the date of event is provided as a best estimate (b)(6) 2022) based on the reported event.Not returned.

• Brand Name: PERMAFIX ENHANCED
• Common Device Name: STAPLE, IMPLANTABLE
• 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: 15410353
• Report Number: 1213643-2022-00619
• Device Sequence Number: 20582775
• Product Code: GDW
• UDI-Device Identifier: 00801741016721
• UDI-Public: (01)00801741016721
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K111153
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/30/2022

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: 01/28/2024
• Device Catalogue Number: 0113120
• Device Lot Number: HUFN1882
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/21/2022
• Initial Report FDA Received Date: 09/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2021
• 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