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

Catalog Number	0113115
Medical Device Problem Code	Failure to Form Staple (2579)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during a laparoscopic inguinal hernia repair procedure, a sorbafix enhanced device was used.It was reported that the device fixated first four fasteners successfully and during fifth fastener, it did not fixate.It was reported that there was no loose fastener present in patient's body and the fastener was deployed around the cooper¿s ligament with adequate counter pressure applied.The procedure was completed using another device.There was no patient injury.
Additional Manufacturer Narrative
As reported, sorbafix enhanced failed to fixate.Evaluation of the photo and sample is inconclusive as the device was received with all 15 fasteners have been deployed prior to the sample return.Functional and simulated use testing could not be performed.Photos provided are unclear if the image is showing a loose fastener as none were reported to have been loose in the body.Photo review does not assist in determining root cause.No manufacturing anomalies were found.Review of manufacturing records shows product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units.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: SORBAFIX ENHANCED
• 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: 21752638
• Report Number: 1213643-2025-00288
• Device Sequence Number: 15519741
• Product Code: GDW
• UDI-Device Identifier: 00801741016691
• UDI-Public: (01)00801741016691(11)240806(17)260728(10)HUJV0295
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K111153
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/17/2025

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: 0113115
• Device Lot Number: HUJV0295
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2025
• Initial Report FDA Received Date: 04/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/06/2024
• 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