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

Catalog Number	0113315
Medical Device Problem Codes	Break (1069); Failure to Form Staple (2579)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during a laparoscopic inguinal hernia repair procedure on (b)(6) 2022, the bard/davol optifix at was used to fixate a bard mesh into the soft tissue region in the straight position.As reported, the first fastener did not fixate the mesh and the second fastener broke.As reported, the proud/loose fasteners were removed from the patient body and there was no reported patient injury.
Additional Manufacturer Narrative
As reported, the optifix at fixation device did not fixate the mesh and deployed a broken fastener, which were removed and there was no reported patient injury.The subject device is reported to be available for evaluation, however, at this time has not been received.Based on the information available and without having the sample to evaluate, no conclusions can be made.The instructions-for-use (ifu) supplied with the device adequately describe the proper technique for fastener delivery and includes "care should be taken not to use excessive counter pressure as this may damage the distal tip of the device as well as the mesh and/or tissue." if/when the sample is returned and evaluated, a supplemental mdr will be submitted.Not returned.
Event or Problem Description
As reported, during a laparoscopic inguinal hernia repair procedure on 29-apr-2022, the bard/davol optifix at was used to fixate a bard mesh into the soft tissue region in the straight position.As reported, the first fastener did not fixate the mesh and the second fastener broke.As reported, the proud/loose fasteners were removed from the patient body and there was no reported patient injury.
Additional Manufacturer Narrative
As reported, the optifix at fixation device did not fixate the mesh and deployed a broken fastener, which were removed and there was no reported patient injury.The subject device is reported to be available for evaluation, however, at this time has not been received.Based on the information available and without having the sample to evaluate, no conclusions can be made.The instructions-for-use (ifu) supplied with the device adequately describe the proper technique for fastener delivery and includes "care should be taken not to use excessive counter pressure as this may damage the distal tip of the device as well as the mesh and/or tissue." addendum: this is an addendum to the initial mdr submitted.This supplemental mdr is submitted to document the sample evaluation results.The subject device was returned for evaluation.A functional evaluation could not be performed as the device was received empty.No manufacturing anomalies were found.Based on the sample evaluation and investigation performed, the root cause is inconclusive as an attempt to reproduce the reported event could not be performed.Review of manufacturing records confirms product was manufactured 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 (b)(4) units released for distribution in october,2021.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 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: 14462316
• Report Number: 1213643-2022-00260
• Device Sequence Number: 4504048
• Product Code: GDW
• UDI-Device Identifier: 00801741136559
• UDI-Public: (01)00801741136559
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2022

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: 07/28/2022
• Device Catalogue Number: 0113315
• Device Lot Number: HUEV0953R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/29/2022
• Supplement Date Received by Manufacturer: 05/27/2022
• Initial Report FDA Received Date: 05/20/2022
• Supplement Report FDA Received Date: 06/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/13/2021
• 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