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	01/30/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, during a procedure, the sorbafix enhanced device failed to fire the fasteners and when the surgeon attempted a dry fire after removing the sorbafix device and gripping it firmly, the damaged fastener came out.The subject device is being returned for evaluation; however, at this time it has not been received.Based on the information available and without having the 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.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 procure on (b)(6) 2026, the sorbafix enhanced fixation device was jammed while being triggered or actuated.It was stiff from the first shot and could not be gripped properly.The surgeon removed the device and performed a dry fire while holding it firmly, which resulted in the release of a damaged fastener.Another sorbafix device was used to complete the procedure.There was no patient injury.
Additional Manufacturer Narrative
As reported, during a procedure, the sorbafix enhanced device failed to fire the fasteners and when the surgeon attempted a dry fire after removing the sorbafix device and gripping it firmly, the damaged fastener came out.The subject device is being returned for evaluation; however, at this time it has not been received.Based on the information available and without having the 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.Addendum: this is an addendum to the initial mdr submitted to document the sample evaluation results.The evaluation of returned sample finds, the reported fastener break could not be reproduced based on the sample condition due to the mandrel component becoming detached.This suggests that mandrel was not engaged and fully crimped.The root cause of the found condition is determined as manpower since a weak crimp could be generated during manufacturing process and not detected during the assembly process.A general awareness was provided to sorbafix personnel to emphasize device assembly requirements.Updated fields: b4, d9, 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 a procure on (b)(6) 2026 the sorbafix enhanced fixation device was jammed while being triggered or actuated.It was stiff from the first shot and could not be gripped properly.The surgeon removed the device and performed a dry fire while holding it firmly, which resulted in the release of a damaged fastener.Another sorbafix 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: 24388481
• Report Number: 1213643-2026-00186
• Device Sequence Number: 21462182
• Product Code: GDW
• UDI-Device Identifier: 00801741016707
• UDI-Public: (01)00801741016707(17)260228(10)HUJQ0976
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 03/02/2026

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: 02/28/2026
• Device Catalogue Number: 0113116
• Device Lot Number: HUJQ0976
• 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: 02/04/2026
• Supplement Date Received by Manufacturer: 03/24/2026
• Initial Report FDA Received Date: 02/19/2026
• Supplement Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/09/2024
• 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