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

Catalog Number	0113330
Medical Device Problem Code	Failure to Form Staple (2579)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, alleged optifix at failed to fixate the mesh.The subject device was not returned for evaluation.Based on the information provided and without having the sample to evaluate, no conclusions can be made.Review of manufacturing records shows product was made to specification, with no indication of a manufacturing related cause for the event reported.To date, this is the only reported complaint for this manufacturing lot of 475 units.This mdr represents the optifix at (device # 3).An additional mdr's were submitted to represent the optifix at (device #1 and device # 2).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 procedure, the optifix at fixation device was used to fixate the mesh.It was reported that the fastener did not fixate the mesh and there was too much concern regarding a potential patient safety issue.There was no patient injury.This file represents device # 3.
Additional Manufacturer Narrative
As reported, alleged optifix at failed to fixate the mesh.The subject device was not returned for evaluation.Based on the information provided and without having the sample to evaluate, no conclusions can be made.Review of manufacturing records shows product was made to specification, with no indication of a manufacturing related cause for the event reported.To date, this is the only reported complaint for this manufacturing lot of 490 units.Addendum: this is an addendum to the initial mdr submitted.This supplemental mdr is submitted to document the sample evaluation results.Evaluation of the same lot sample did not reproduce the reported event of failed to fixate and did not assist in determining root cause for the reported event.Without the original sample no conclusion can be made.This supplemental emdr represents the optifix at (device #3).Additional supplemental emdr's were submitted to represent the optifix at (device #1 and device #2).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 procedure, the optifix at fixation device was used to fixate the mesh.It was reported that the fastener did not fixate the mesh and there was too much concern regarding a potential patient safety issue.There was no patient injury.This file represents device #3.

• 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: 21214442
• Report Number: 1213643-2025-00019
• Device Sequence Number: 3378363
• Product Code: GDW
• UDI-Device Identifier: 00801741136566
• UDI-Public: (01)00801741136566(17)260728(10)HUJV0405
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2025

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: 07/28/2026
• Device Catalogue Number: 0113330
• Device Lot Number: HUJV0405
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2025
• Supplement Date Received by Manufacturer: 02/18/2025
• Initial Report FDA Received Date: 01/22/2025
• Supplement Report FDA Received Date: 03/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/14/2024
• 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