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

Catalog Number	0113119
Medical Device Problem Code	Failure to Form Staple (2579)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, the permafix enhanced fixation failed to fixate the mesh after two successful deployments.The subject device was returned for evaluation depleted of all fifteen fasteners.As such, a functional test to attempt to reproduce the reported event could not be performed.The device handle cover was removed finding all the components in place and in good condition.No manufacturing anomalies were found.Based on the sample evaluation and investigation performed, the root cause is inconclusive.Review of manufacturing records confirms product was manufactured to specification, with no indication of a manufacturing related cause for the event reported.The instructions-for-use(ifu) supplied with the device states: " avoid excessive trigger force as this may damage the device.If the device locks, remove the device from the patient and lightly tap the trigger forward toward the tip to release.If the device locks and cannot be separated from a fastener that has been deployed into tissue, you may rotate the device counter clockwise to free the device.The locked device should then be discarded and a new device should be used.If the fastener does not deploy properly, remove the device from the patient and test the device in air to ensure proper fastener deployment.Once proper fastener deployment is confirmed, the device may be reinserted into the patient.".
Event or Problem Description
As reported, during an unknown procedure on (b)(6) 2022, the bard/davol permafix enhanced fixation device was used to fixate an unknown mesh.As reported, two fasteners successfully fixated the mesh and the third and subsequent fasteners did not pierce the tissue.The device stopped firing after firing several fasteners.The fasteners that did not fixate the mesh were removed from the patient and there were no broken fasteners.There was no reported patient injury.

• 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: 14434367
• Report Number: 1213643-2022-00229
• Device Sequence Number: 5579069
• Product Code: GDW
• UDI-Device Identifier: 00801741016714
• UDI-Public: (01)00801741016714
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K111153
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 04/27/2022

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: 02/28/2024
• Device Catalogue Number: 0113119
• Device Lot Number: HUFQ1452
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/25/2022
• Initial Report FDA Received Date: 05/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/21/2021
• 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