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

Catalog Number	0113116
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during a surgical procedure, the sorbafix enhanced fixation device's fasteners failed to deploy.The fasteners failed to come out of the shaft of the device.When the surgeon attempted to move the device outside the patient's cavity, it fired again, releasing all the fasteners of the steel coil simultaneously.It was reported that the issue is believed to have occurred due to exposure to high temperatures during transportation, despite the distributor being instructed on the handling and transporting procedures and the temperature precautions.There was no patient injury.
Additional Manufacturer Narrative
As reported, during a procedure the sorbafix enhanced fixation device failed to fixate the fasteners, making all the fasteners to come out of the steel coil altogether.The photos/video do not assist in determining root cause, but it is likely there is detachment of an internal component allowing the mandrel to become extended far beyond the cannula.Based on the information available and without having the sample to evaluate, no conclusions can be made.A review of manufacturing records was performed and found that the device was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units.Note, the date of event (02-feb-2026) is considered to be a best estimate based on the date of awaremess.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.
Additional Manufacturer Narrative
As reported, during a procedure the sorbafix enhanced fixation device failed to fixate the fasteners, making all the fasteners to come out of the steel coil altogether.The photos/video do not assist in determining root cause, but it is likely there is detachment of an internal component allowing the mandrel to become extended far beyond the cannula.Based on the information available and without having the sample to evaluate, no conclusions can be made.A review of manufacturing records was performed and found that the device was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of 465 units.Note, the date of event (02-feb-2026) is considered to be a best estimate based on the date of awareness.Addendum: h11: this is an addendum to the initial mdr submitted.This supplemental mdr is submitted to correct the sample evaluation findings and to correct the imdrf b grid and imdrf c grid.Based on the information available and without having the sample to evaluate, a definitive root cause could not be determined.Updated fields: b4, g3, g6, h2, h11.Corrected fields: h6 (imdrf annex b grid, imdrf annex c grid) , 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 surgical procedure, the sorbafix enhanced fixation device's fasteners failed to deploy.The fasteners failed to come out of the shaft of the device.When the surgeon attempted to move the device outside the patient's cavity, it fired again, releasing all the fasteners of the steel coil simultaneously.It was reported that the issue is believed to have occurred due to exposure to high temperatures during transportation, despite the distributor being instructed on the handling and transporting procedures and the temperature precautions.There was no patient injury.
Additional Manufacturer Narrative
As reported, during a procedure the sorbafix enhanced fixation device failed to fixate the fasteners, making all the fasteners to come out of the steel coil altogether.The photos/video do not assist in determining root cause, but it is likely there is detachment of an internal component allowing the mandrel to become extended far beyond the cannula.Based on the information available and without having the sample to evaluate, no conclusions can be made.A review of manufacturing records was performed and found that the device was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units.Addendum 1: h11: this is an addendum to the initial mdr submitted.This supplemental mdr is submitted to correct the sample evaluation findings and to correct the imdrf b grid and imdrf c grid.Based on the information available and without having the sample to evaluate, a definitive root cause could not be determined.Updated fields: b4, g3, g6, h2, h11.Corrected fields: h6 (imdrf annex b grid, imdrf annex c grid), h10 (manufacturer narrative).Addendum 2: h11: this is an addendum to the initial mdr submitted to document additional information provided and to correct the event date.Updated fields: b4, e1, e3, g3, g6, h2, h10, h11.Corrected field: b3 (date of event).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 surgical procedure, the sorbafix enhanced fixation device's fasteners failed to deploy.The fasteners failed to come out of the shaft of the device.When the surgeon attempted to move the device outside the patient's cavity, it fired again, releasing all the fasteners of the steel coil simultaneously.It was reported that the issue is believed to have occurred due to exposure to high temperatures during transportation, despite the distributor being instructed on the handling and transporting procedures and the temperature precautions.There was no patient injury.Addendum per additional information provided: as reported, during a surgical procedure on (b)(6) 2026, the jam occurred during activation at the first staple.The fasteners are contained within the mandrel and could not be removed as they were completely glued.The fixation was applied directly to the abdominal wall, not to any rigid structure, bone, or cooper¿s ligament.

• 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: 24401077
• Report Number: 1213643-2026-00190
• Device Sequence Number: 9859073
• Product Code: GDW
• UDI-Device Identifier: 00801741016707
• UDI-Public: (01)00801741016707(11)250411(17)270328(10)HUKQ1731
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/31/2026

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 Catalogue Number: 0113116
• Device Lot Number: HUKQ1731
• 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: 02/02/2026
• Supplement Date Received by Manufacturer: 02/23/2026; 03/31/2026
• Initial Report FDA Received Date: 02/20/2026
• Supplement Report FDA Received Date: 02/27/2026; 04/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/11/2025
• 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: Male