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

Catalog Number	0113126
Medical Device Problem Code	Failure to Form Staple (2579)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, during the procedure, while securing the mesh, the optifix straight fastener did not hold and fell off.The evaluation of the returned sample finds for bent guide wire and backup tabs.The reported failed to fixate are a known result of bent guide wire and backup tabs.The components are found to be bent from applied forces while in use.No manufacturing anomies were found.The precautions section of ifu states "care should be taken not to use excessive counterpressure as this may damage the distal tip of the device as well as the mesh and/or tissue." a review of manufacturing records was performed and found that the device was manufactured to specification.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.
Event or Problem Description
As reported, during a laparoscopic umbilical hernia repair, the fasteners did not hold and fell off while the ventralex mesh was being fixated to the abdominal soft tissue using the optifix fixation device.It was noted that the first three fasteners were fixated with the mesh, the subsequent three did not fixate and became loose.The loose fasteners were removed from the patient's body, resulting in loss of operating time.Another device was used to complete the procedure.There was no patient injury.

• Brand Name: OPTIFIX STRAIGHT
• 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: 24567906
• Report Number: 1213643-2026-00312
• Device Sequence Number: 21222908
• Product Code: GDW
• UDI-Device Identifier: 00801741074318
• UDI-Public: (01)00801741074318(17)260728(10)HUJV0844
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K142873
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 02/19/2026

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: 07/28/2026
• Device Catalogue Number: 0113126
• Device Lot Number: HUJV0844
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2026
• Initial Report FDA Received Date: 03/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/07/2024
• 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