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	07/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, the sorbafix enhanced fixation device failed to fixate properly.An interoperative photo was provided.Present in the photo is at least one fastener that appears to be not fully fixated to the mesh (proud).However, review is inconclusive.A same lot sample is reported to be available for evaluation; however, at this time it has not been received.Based on the information available at this time and without having a physical 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.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 laparoscopic abdominal wall hernia surgery, the sorbafix enhanced fixation device failed to fixate properly.It was reported that only a few fasteners could be fixated and it was very difficult to fixate the mesh.There was no patient injury.
Additional Manufacturer Narrative
As reported, the sorbafix enhanced fixation device failed to fixate properly.An interoperative photo was provided.Present in the photo is at least one fastener that appears to be not fully fixated to the mesh (proud).However, review is inconclusive.A same lot sample is reported to be available for evaluation; however, at this time it has not been received.Based on the information available at this time and without having a physical 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.Addendum: h11: this supplemental emdr is submitted to correct the annex c code & term and manufacture narrative.Available photo evaluation confirmed the reported issue; however, it did not yield a definitive root cause.Based on the information available and without having the sample to evaluate, no conclusions can be made.Updated fields: b4, g3, g6, h2, h11 corrected field: h6 (annex code & term), h10(manufacturer narrative) 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 laparoscopic abdominal wall hernia surgery, the sorbafix enhanced fixation device failed to fixate properly.It was reported that only a few fasteners could be fixated and it was very difficult to fixate the mesh.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: 22797159
• Report Number: 1213643-2025-00755
• Device Sequence Number: 12889724
• Product Code: GDW
• UDI-Device Identifier: 00801741016691
• UDI-Public: (01)00801741016691(11)240927(17)260828(10)HUJW1613
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K111153
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2025

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: 08/28/2026
• Device Catalogue Number: 0113115
• Device Lot Number: HUJW1613
• 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: 07/26/2025
• Supplement Date Received by Manufacturer: 08/14/2025
• Initial Report FDA Received Date: 08/13/2025
• Supplement Report FDA Received Date: 09/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/27/2024
• 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