MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 SORBAFIX ENHANCED; STAPLE, IMPLANTABLE

Catalog Number	0113116
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, during eventration repair procedure, sorbafix enhanced deployed staples were brittle and broke during insertion.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.To date, this is the only reported complaint from this manufacturing lot of (b)(4) units.Addendum: this is an addendum to the initial mdr submitted to document the sample evaluation results.A definitive root cause as to why the fasteners broke in use could not be determined.The evaluation of the returned sample was inconclusive.Functional and simulated use testing could not be conducted due to the device being received in a condition where all 30 fasteners had already been deployed.No broken fasteners were returned.No manufacturing anomalies were found.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 eventration repair procedure on (b)(6) 2025, sorbafix enhanced deployed staples were brittle and broke during insertion.This incident resulted in a loss of operating time for the team and excessive consumption of materials.It was also reported that none of the fasteners got fired successfully and another device was used to complete the procedure.There was no patient injury.
Additional Manufacturer Narrative
As reported, during eventration repair procedure, sorbafix enhanced deployed staples were brittle and broke during insertion.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.To date, this is the only reported complaint from this manufacturing lot of (b)(4) units.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 eventration repair procedure on (b)(6) 2025, sorbafix enhanced deployed staples were brittle and broke during insertion.This incident resulted in a loss of operating time for the team and excessive consumption of materials.It was also reported that none of the fasteners got fired successfully and 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: 24270551
• Report Number: 1213643-2026-00091
• Device Sequence Number: 10120812
• Product Code: GDW
• UDI-Device Identifier: 00801741016707
• UDI-Public: (01)00801741016707(11)240503(17)260428(10)HUJS0486
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K111153
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2026

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 Expiration Date: 04/28/2026
• Device Catalogue Number: 0113116
• Device Lot Number: HUJS0486
• 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: 01/15/2026
• Supplement Date Received by Manufacturer: 02/11/2026
• Initial Report FDA Received Date: 02/05/2026
• Supplement Report FDA Received Date: 02/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/03/2024
• 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