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	02/11/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, the sorbafix fasteners failed to properly fixate the mesh while fixating at preperitoneal area.The video provided confirms that two out of five fasteners did not fixate the mesh to the tissue wall.However, the video do not assist in determining root cause and it cannot be determined f the device as short filled.The sample is said to be available for evaluation; however, at this time it has not been received.Based on the information available and without having the sample to evaluate, 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 released for distribution.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 unilateral left laparoscopic inguinal hernia repair procedure, sorbafix fixation device had only ten fasteners instead of thirty fasteners.Additionally, the sorbafix fasteners failed to properly fixate the mesh while fixating the mesh at preperitoneal area.The surgeon usually uses three fasteners but had to use 10 to 15 fasteners to secure the mesh.The procedure was completed using same device and it was confirmed that a separate device is used for every patient.There was no patient injury.
Additional Manufacturer Narrative
As reported, the sorbafix fasteners failed to properly fixate the mesh while fixating at preperitoneal area.The video provided confirms that two out of five fasteners did not fixate the mesh to the tissue wall.However, the video do not assist in determining root cause and it cannot be determined f the device as short filled.The sample is said to be available for evaluation; however, at this time it has not been received.Based on the information available and without having the sample to evaluate, 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 released for distribution.Addendum: this is an addendum to the initial mdr submitted to document the sample evaluation results.Evaluation of the sample failed to reproduce the reported event.The device functioned as intended during functional and simulated use testing.The event that device was short filled could not be confirmed.Nine fasteners remained in the device as received.No manufacturing anomalies were found.Updated fields: b4, d9, g3, g6, h2, h3, h6, h10.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 unilateral left laparoscopic inguinal hernia repair procedure, sorbafix fixation device had only ten fasteners instead of thirty fasteners.Additionally, the sorbafix fasteners failed to properly fixate the mesh while fixating the mesh at preperitoneal area.The surgeon usually uses three fasteners but had to use 10 to 15 fasteners to secure the mesh.The procedure was completed using same device and it was confirmed that a separate device is used for every patient.There was no patient injury.

• 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: 24535769
• Report Number: 1213643-2026-00292
• Device Sequence Number: 10343332
• Product Code: GDW
• UDI-Device Identifier: 00801741016707
• UDI-Public: (01)00801741016707(11)241223(17)261128(10)HUJZ1000
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2026

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: HUJZ1000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2026
• Supplement Date Received by Manufacturer: 03/12/2026
• Initial Report FDA Received Date: 03/06/2026
• Supplement Report FDA Received Date: 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/23/2024
• 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 Age: 66 YR
• Patient Sex: Male
• Patient Weight: 68 KG