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

Catalog Number	0113127
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, on (b)(6) 2025 during a procedure optifix fixation device was used to secure the 3dmax light mesh.It was reported that the fastener broke while fixating the 3dmax light mesh in to the pubic bone area and the broken fasteners were removed from the patient's body.The device failed to fire during dry firing.Another device was used to complete the procedure.There was no reported patient harm or injury.
Additional Manufacturer Narrative
As reported, during the mesh placement the optifix fastener broke, and the device failed to fire during dry firing.Evaluation of the sample finds for bent guide wire and backup tabs.The reported deployed broken fastener is a known result of bent guide wire and bent backup tabs.The components are found to be bent from applied forces while in use.No manufacturing anomies were found.Review of manufacturing records confirms product was manufactured to specification.The instructions-for-use supplied with the device adequately describe the proper technique for fastener delivery.The precautions section 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¿ and ¿insertion of fasteners is possible into some collagenous structures such as ligaments and tendons but is not possible directly into bone or cartilage.This may damage the device and result in compromised fixation strength¿.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.

• 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: 23802873
• Report Number: 1213643-2025-01205
• Device Sequence Number: 12684229
• Product Code: GDW
• UDI-Device Identifier: 00801741074325
• UDI-Public: (01)00801741074325(17)260828(10)HUJV1797
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K142873
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 11/20/2025

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: 08/28/2026
• Device Catalogue Number: 0113127
• Device Lot Number: HUJV1797
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2025
• Initial Report FDA Received Date: 12/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/18/2024
• 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