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

Catalog Number	0113115
Medical Device Problem Code	Failure to Form Staple (2579)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, the sorbafix enhanced fixation device did not fixate the mesh.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 deploying the 10 remaining fasteners from the 15 count device without any issue.No manufacturing anomalies were found.Review of manufacturing records shows product was made to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in january 2024.The instructions-for-use (ifu) supplied with the device adequately describe the proper technique for successful fastener delivery.The ifu states, "compress handpiece trigger in a single, complete and uninterrupted stroke to drive an absorbable fastener through the mesh into the tissue.Keep consistent pressure on the tip of the device through the entire stroke.Release the trigger allowing it to return completely to its resting position.Repeat this procedure until all required fasteners are deployed".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 laparoscopic inguinal hernia repair procedure the surgeon tried to fixate the 3dmax light mesh using sorbafix enhanced fixation device on (b)(6) 2024.It was reported that the fixation device did not fixate the mesh at the area of cooper ligament.It was also reported that there were no broken fasteners, and the procedure was completed with successfully fixated fasteners.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: 20396859
• Report Number: 1213643-2024-00483
• Device Sequence Number: 3579076
• Product Code: GDW
• UDI-Device Identifier: 00801741016691
• UDI-Public: (01)00801741016691(17)251028(10)HUHY1657
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K111153
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/24/2024

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: 10/28/2025
• Device Catalogue Number: 0113115
• Device Lot Number: HUHY1657
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2024
• Initial Report FDA Received Date: 10/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/17/2024
• 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