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	01/13/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, during a procedure when using sorbafix enhanced fixation the device did not shoot properly and the mesh could not be fixed.The subject device is being returned for evaluation but has not yet been received.Based on the information provided and not having the physical sample to evaluate no conclusions can be made.If/when the sample is returned and evaluated a supplemental mdr will be submitted to document the evaluation results.Review of manufacturing records confirms product 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.
Event or Problem Description
As reported, during ipom procedure when using sorbafix enhanced fixation the device did not shoot properly and the mesh could not be fixed.The fastener detached and fell out after 2¿3 fixations, with loose or protruding fasteners noted but no defects identified.There was no damage to the device tip.Another device was used to complete the procedure.There was no patient injury.
Additional Manufacturer Narrative
As reported, during a procedure when using sorbafix enhanced fixation the device did not shoot properly and the mesh could not be fixed.The subject device is being returned for evaluation but has not yet been received.Based on the information provided and not having the physical sample to evaluate no conclusions can be made.If/when the sample is returned and evaluated a supplemental mdr will be submitted to document the evaluation results.Review of manufacturing records confirms product was manufactured to specification.Addendum: this is an addendum to the initial mdr submitted to document the implant date and sample evaluation results.The evaluation of the returned sample could not reproduce the reported event of failed to fixate.The device functioned as intended during functional and simulated use testing, successfully fixating the remaining seven fasteners into mesh.No manufacturing anomalies were found.Updated fields: b4, d9, d.6a (date of implant), 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 ipom procedure when using sorbafix enhanced fixation the device did not shoot properly and the mesh could not be fixed.The fastener detached and fell out after 2-3 fixations, with loose or protruding fasteners noted but no defects identified.There was no damage to the device tip.Another device was used to complete the procedure.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: 24270563
• Report Number: 1213643-2026-00092
• Device Sequence Number: 21319186
• Product Code: GDW
• UDI-Device Identifier: 00801741016707
• UDI-Public: (01)00801741016707(11)240809(17)260728(10)HUJV0495
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2026

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 Expiration Date: 07/28/2026
• Device Catalogue Number: 0113116
• Device Lot Number: HUJV0495
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2026
• Supplement Date Received by Manufacturer: 02/20/2026
• Initial Report FDA Received Date: 02/05/2026
• Supplement Report FDA Received Date: 02/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/09/2024
• 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