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	01/24/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, the bard/davol permafix fixation device was used to fixate an unspecified mesh using adequate counter-pressure in a laparoscopic procedure on (b)(6) 2022.As reported, a few fasteners successfully fixated the mesh, after which the fasteners did not adequately fixate the mesh.As reported, the loose fasteners were removed from the patient¿s body.As reported, the device was dry-fired and the issue occurred again.The procedure was completed using another permafix device and there was no reported patient injury.
Additional Manufacturer Narrative
As reported, the bard/davol permafix fasteners did not fixate the mesh.At this time the sample has not been provided for review.However, an intra-operative video was provided which indicates that the user is not applying enough counter pressure.It also appears that the user may not be maintaining the counter-pressure during the entire trigger pull.Based on the information provided and video review, root cause of the fasteners not fixating is lack of counter-pressure while in use.No lot number has been provided; therefore, a review of the manufacturing records is not possible.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.Not returned.
Additional Manufacturer Narrative
As reported, the bard/davol permafix fasteners did not fixate the mesh.At this time the sample has not been provided for review.However, an intra-operative video was provided which indicates that the user is not applying enough counter pressure.It also appears that the user may not be maintaining the counter-pressure during the entire trigger pull.Based on the information provided and video review, root cause of the fasteners not fixating is lack of counter-pressure while in use.No lot number has been provided; therefore, a review of the manufacturing records is not possible.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." addendum: this is an addendum to the initial mdr submitted.This supplemental mdr is submitted to report the lot no., and results of the device evaluation.The subject device was returned for evaluation.Based on the sample evaluation and investigation performed, the reported event is confirmed.Evaluation of the sample finds the cannula is bent from forces applied while in use.The bent cannula resulted in the reported and found failure to fixate.Damage was also found to internal components because of force applied during use of the device.Review of the device history records confirmed the device was manufactured to specification, with no indication of a manufacturing related cause for the event reported.To date, this is the only reported complaint for this manufacturing lot of 415 units released for distribution in december, 2020.Updated fields: b4, d4 (medical device lot #, medical device expiration date), d9, g3, g6, h2, h3, h4 (device manufacture date), h6, h10 note: section a through f - the information provided by bd 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 bd.H3 other text : sample evaluated.
Event or Problem Description
As reported, the bard/davol permafix fixation device was used to fixate an unspecified mesh using adequate counter-pressure in a laparoscopic procedure on (b)(6)2022.As reported, a few fasteners successfully fixated the mesh, after which the fasteners did not adequately fixate the mesh.As reported, the loose fasteners were removed from the patient¿s body.As reported, the device was dry-fired and the issue occurred again.The procedure was completed using another permafix device and 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: 13670569
• Report Number: 1213643-2022-00047
• Device Sequence Number: 14641664
• Product Code: GDW
• UDI-Device Identifier: 00801741016714
• UDI-Public: (01)00801741016714
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2022

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: 11/28/2023
• Device Catalogue Number: 0113119
• Device Lot Number: HUEY0763
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/15/2022
• Supplement Date Received by Manufacturer: 07/27/2022
• Initial Report FDA Received Date: 03/04/2022
• Supplement Report FDA Received Date: 08/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/17/2020
• 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