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	01/05/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, during post-incisional hernia procedure using optifix straight fixation device the first four fasteners fixated the mesh, however, the subsequent ones did not did not fixate the mesh.The sample was discarded as such not available for evaluation.Based on the information provided and without having the sample to evaluate, no conclusion can be made.A review of manufacturing records was performed and found the device was manufactured to specification.Addendum: this is an addendum to the initial mdr submitted to document the photo evaluation results.Evaluation of the photo provided confirms the presence of six loose fasteners laying on blue surgical paper and the backup tabs on the device are bent.Based on the photos provided the back tabs are found to have likely bent from forces applied in use.Bent backup tabs are known cause for the reported failure to fixate.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 post-incisional hernia procedure using optifix straight fixation device the first four fasteners fixated the mesh, however, the subsequent ones did not come out with enough force and therefore did not fixate.The loose fasteners were removed from the patient's body and another device was used to complete the procedure.The device was discarded, as it was contaminated with blood.There was no patient injury.
Event or Problem Description
As reported, during post-incisional hernia procedure using optifix straight fixation device the first four fasteners fixated the mesh, however, the subsequent ones did not come out with enough force and therefore did not fixate.The loose fasteners were removed from the patient's body and another device was used to complete the procedure.The device was discarded, as it was contaminated with blood.There was no patient injury.
Additional Manufacturer Narrative
As reported, during post-incisional hernia procedure using optifix straight fixation device the first four fasteners fixated the mesh, however, the subsequent ones did not did not fixate the mesh.The sample was discarded as such not available for evaluation.Based on the information provided and without having the sample to evaluate, no conclusion can be made.A review of manufacturing records was performed and found 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.

• 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: 24202210
• Report Number: 1213643-2026-00045
• Device Sequence Number: 9662132
• Product Code: GDW
• UDI-Device Identifier: 00801741074318
• UDI-Public: (01)00801741074318(17)261128(10)HUJZ0486
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2026

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 Catalogue Number: 0113126
• Device Lot Number: HUJZ0486
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2026
• Supplement Date Received by Manufacturer: 01/29/2026
• Initial Report FDA Received Date: 01/28/2026
• Supplement Report FDA Received Date: 02/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/04/2025
• 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