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	05/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during a right inguinal hernia repair procedure, the sorbafix enhanced device failed to fixate after deploying two (2) fasteners as the fastener's kept "coming off the tissue".The loose fasteners were removed from the patient and another device was used to complete the procedure.There was no patient harm or injury.
Additional Manufacturer Narrative
As reported, during a right inguinal hernia repair procedure, the sorbafix enhanced device failed to fixate after deploying two (2) fasteners as the fastener's kept "coming off the tissue".The sample was returned depleted of all fasteners.Evaluation of the returned sample finds the cannula shaft is bent and the tip of the cannula is crushed.Due to the as-received condition, functional testing could not be performed.A bend of this nature and the crush at the tip would not go unnoticed at point of use.The damage most likely occurred after use.No manufacturing anomalies were found.Based on the returned sample condition no conclusions can be made.A review of the manufacturing records was performed and found that the lot was manufactured to the specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units.The instructions-for-use (ifu) supplied with the device adequately describe the proper technique for successful fastener delivery.The precautions section of the ifu supplied with the device states, "avoid excessive trigger force as this may damage the device." 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: 25205242
• Report Number: 1213643-2026-00647
• Device Sequence Number: 15973172
• Product Code: GDW
• UDI-Device Identifier: 00801741016691
• UDI-Public: (01)00801741016691(11)250623(17)270528(10)HUKT1135
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K111153
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/05/2026

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: 0113115
• Device Lot Number: HUKT1135
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2026
• Initial Report FDA Received Date: 05/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/23/2025
• 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