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

Catalog Number	0113116
Medical Device Problem Code	Failure to Form Staple (2579)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2026
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during a laparoscopic incisional hernia repair procedure, the sorbafix enhanced fixation device failed to secure the mesh after multiple attempts.The fixation was attempted at the abdominal soft tissue with adequate counter-pressure; however, the fasteners failed to deploy and secure.The loose fasteners were removed from the patient, and another device was used to complete the procedure.Reportedly, the surgeon had prior experience using this product.There was no patient harm or injury.
Additional Manufacturer Narrative
As reported, during a procedure, the sorbafix enhanced fixation device failed to secure the mesh after multiple attempts.The loose fasteners were removed from the patient.The image provided shows the sorbafix fixation device has no visible damage to the device housing, and the trigger is not actuated.Also, there are twelve (12) loose fasteners lying next to the device.However, photo does not assist in determining root cause.The subject device was discarded and is not available for evaluation.Based on the information provided and without having the sample to evaluate, a definitive root cause cannot be determined.A review of manufacturing records was performed and found that 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: 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: 25410442
• Report Number: 1213643-2026-00719
• Device Sequence Number: 21443808
• Product Code: GDW
• UDI-Device Identifier: 00801741016707
• UDI-Public: (01)00801741016707(11)250925(17)270828(10)HUKW1167
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K111153
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/27/2026

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: 0113116
• Device Lot Number: HUKW1167
• 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: 05/19/2026
• Initial Report FDA Received Date: 06/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/25/2025
• 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