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

Catalog Number	0113330
Medical Device Problem Codes	Break (1069); Failure to Form Staple (2579)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, optifix at failure to fixate, deployed broken fasteners when dry fired.Evaluation of the sample finds did not reproduce the reported event as the device was found to deploy with no anomalies.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, supplied with this device states, "place the tip of the optifix¿ at absorbable fixation system at the desired location perpendicular to the mesh or tissue and apply adequate counterpressure.Different types of mesh may require different amounts of counterpressure.Adjust angle and counterpressure appropriately".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, during an inguinal hernia procedure, the optifix at fixation device did not exhibit force to release fasteners properly, causing the fasteners to fall off the mesh/tissue when attempting to fixate.It was reported that the loose fasteners were removed from the patient.It was also reported that when attempting to dry fire outside of the patient, the device deployed broken fasteners.There was no patient injury.

• 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: 18516714
• Report Number: 1213643-2023-00532
• Device Sequence Number: 20722428
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/27/2023

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: 08/28/2024
• Device Catalogue Number: 0113330
• Device Lot Number: HUGW0317
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2023
• Initial Report FDA Received Date: 01/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/19/2022
• 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