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	07/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, sorbafix enhanced fixation device failed to fixate properly.A same lot sample is reported to be available for evaluation; however, at this time 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.If/when the same lot sample is returned and evaluated a supplemental mdr will be submitted.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 hiatal hernia repair procedure on (b)(6) 2025, a sorbafix enhanced fixation device was deployed into peritoneum and failed to fixate properly.It was reported that no dry fire was attempted, and the procedure was completed using another device.The surgeon is well experienced handling the device and counter pressure was added while fixating the mesh.There was no patient injury.
Additional Manufacturer Narrative
As reported, sorbafix enhanced fixation device failed to fixate properly.A same lot sample is reported to be available for evaluation; however, at this time 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.If/when the same lot sample is returned and evaluated a supplemental mdr will be submitted.Addendum: this is an addendum to the initial mdr submitted to document the video evaluation results.Video provided confirmed the reported issue of device failed to fixate properly, however the video did not assist in determining a root cause.Based on the information available and without having the sample to evaluate, a definitive root cause for the failure to fixate could not be established.Updated fields: b4, g3, g6, h2, 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 laparoscopic hiatal hernia repair procedure on (b)(6) 2025, a sorbafix enhanced fixation device was deployed into peritoneum and failed to fixate properly.It was reported that no dry fire was attempted, and the procedure was completed using another device.The surgeon is well experienced handling the device and counter pressure was added while fixating 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: 22797149
• Report Number: 1213643-2025-00756
• Device Sequence Number: 8286729
• 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
• Reporter Type: Manufacturer
• Report Source: Other,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: 07/21/2025
• Supplement Date Received by Manufacturer: 08/14/2025
• Initial Report FDA Received Date: 08/13/2025
• Supplement Report FDA Received Date: 09/02/2025
• 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