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

Catalog Number	0113126
Medical Device Problem Codes	Failure to Form Staple (2579); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, the optifix straight fixation device failed to fixate and the rod inside where the tackers are loaded was bent.Evaluation of the photo shows the backup tabs are visibly bent.The video provided shows the surgeon dry/air firing the device, the guide wire is visibly bent.The reported failure to fixate is a known result of bent backup tabs and bent guide wire.The visible bent guide wire is found to bent from applied forces while in use.A review of the manufacturing records was performed and found the lot was manufactured to specification.The instructions-for-use (ifu) supplied with the device adequately describe the proper technique for successful fastener delivery.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" note, the date of event (17-oct-2025) is considered to be a best estimate, based on the date of awareness.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 bilateral hernia surgery, optifix straight fixation device was used to secure the 3dmax mesh.It was observed that during the first shot, the device failed to fixate.Subsequently, during the second shot, the fastener did not come out of the device.It was reported that correct technique of angulation and counterpressure were used while firing.After this failure, when the shaft and tip were examined outside the trocar, it was noted that the rod inside where the tackers are loaded was bent.It was also reported that the box was neither crushed nor damaged.Hence, a new capsure device was used as a replacement.There was no reported 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: 23486084
• Report Number: 1213643-2025-01074
• Device Sequence Number: 10559165
• Product Code: GDW
• UDI-Device Identifier: 00801741074318
• UDI-Public: (01)00801741074318(17)260828(10)HUJV1787
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K142873
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/24/2025

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: 0113126
• Device Lot Number: HUJV1787
• 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: 10/17/2025
• Initial Report FDA Received Date: 11/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/27/2024
• 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