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

Catalog Number	0113330
Medical Device Problem Code	Failure to Form Staple (2579)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during an incisional ventral hernia repair procedure on (b)(6) 2022, the bard/davol optifix at fixation device misfired fasteners when attempting to fixate a non-bard/davol (strattice) mesh.As reported, approximately 15 fasteners were deployed and there were both proud and loose fasteners, which were removed from the operative site.As reported, fixation was not applied at a hard structure and the device misfired more in the articulated position than in the straight position.As reported, a non-bard/davol (protack) device was used to complete the procedure.There was no reported patient injury.
Additional Manufacturer Narrative
Functional evaluation of the sample was unable to reproduce the reported event.The subject optifix at was found to function as intended during simulated use testing in both straight and articulated positions.No manufacturing anomalies were noted.Based on the sample evaluation and investigation performed, the most probable root cause of the reported event would be the result of an event occurring during user/device interface.Review of manufacturing records confirms product was manufactured to specification, with no indication of a manufacturing related cause for the event reported.To date, this is the only complaint reported for this manufacturing lot of (b)(4) units released for distribution in july, 2021.The instructions-for-use (ifu) for the optifix at fixation device prescribes the proper method for use of this device for proper fastener delivery and includes "place the tip of the optifix¿ at absorbable fixation system with articulating technology at the desired location perpendicular to the mesh or tissue and apply adequate counterpressure to ensure fastener is fully deployed.Different types of mesh may require different amounts of counterpressure.".

• Brand Name: OPTIFIX AT
• 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: 13606651
• Report Number: 1213643-2022-00030
• Device Sequence Number: 11226800
• Product Code: GDW
• UDI-Device Identifier: 00801741136566
• UDI-Public: (01)00801741136566
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K191287
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/10/2022

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: 06/28/2023
• Device Catalogue Number: 0113330
• Device Lot Number: HUFU0188
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/04/2022
• Initial Report FDA Received Date: 02/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/29/2021
• 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 Age: 47 YR
• Patient Sex: Female