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

Catalog Number	0113115
Medical Device Problem Code	Unintended Ejection (1234)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, sorbafix enhanced fixation device stuck together and did not fixate the mesh.No additional information has been provided upon request.Based on the information available and without having the sample to evaluate, no conclusions can be made.Review of manufacturing records confirms product was manufactured to specification, with no indication of a manufacturing related cause for the event reported.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 inguinal hernioplasty procedure sorbafix enhanced fixation device was used.It was reported that the fasteners were stuck together and did not fixate the mesh.The procedure was completed using another non-bd device and there was no patient injury.
Additional Manufacturer Narrative
As reported, sorbafix enhanced fixation device stuck together and did not fixate the mesh.No additional information has been provided upon request.Based on the information available and without having the sample to evaluate, no conclusions can be made.Review of manufacturing records confirms product was manufactured to specification, with no indication of a manufacturing related cause for the event reported.Addendum: h11: this supplemental mdr is submitted to correct the imdrf annex b code.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 inguinal hernioplasty procedure sorbafix enhanced fixation device was used.It was reported that the fasteners were stuck together and did not fixate the mesh.The procedure was completed using another non-bd device and there was no patient injury.
Additional Manufacturer Narrative
As reported, sorbafix enhanced fixation device stuck together and did not fixate the mesh.No additional information has been provided upon request.Based on the information available and without having the sample to evaluate, no conclusions can be made.Review of manufacturing records confirms product was manufactured to specification, with no indication of a manufacturing related cause for the event reported.Addendum #1: h11: this supplemental mdr is submitted to correct the imdrf annex b code.Addendum #2: this is an addendum to the initial mdr submitted.This supplemental mdr is submitted to document the sample evaluation results.Evaluation of the device could not reproduce the reported event that the device deployed two fasteners at once and failed to fixate.The device functioned as intended during simulated use testing, deploying the remaining fastener with no issues.No manufacturing anomalies 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 a unilateral inguinal hernioplasty procedure sorbafix enhanced fixation device was used.It was reported that the fasteners were stuck together and did not fixate the mesh.The procedure was completed using another non-bd device and 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: 21826851
• Report Number: 1213643-2025-00307
• Device Sequence Number: 18512054
• Product Code: GDW
• UDI-Device Identifier: 00801741016691
• UDI-Public: (01)00801741016691(11)240529(17)260428(10)HUJS1877
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/09/2025

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: 04/28/2026
• Device Catalogue Number: 0113115
• Device Lot Number: HUJS1877
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2025
• Supplement Date Received by Manufacturer: 04/17/2025; 05/16/2025
• Initial Report FDA Received Date: 04/11/2025
• Supplement Report FDA Received Date: 04/22/2025; 05/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/29/2024
• 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