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

Catalog Number	0113120
Medical Device Problem Code	Failure to Form Staple (2579)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, during a procedure using permafix enhanced fixation device it was observed loose fasteners present.Evaluation of the photos and sample provided confirms the reported event of failure to fixate.The simulation test found that all fasteners deployed did not fixate the mesh.While a definitive root cause cannot be determined, the most likely cause for the failure to fixate is the result of an event occurring during user/ device interface causing the device to go out of synchronization.No manufacturing anomalies were found.The instructions-for-use (ifu) for the permafix fixation device prescribes the proper method for use of this device for proper fastener delivery and includes "place the tip of the permafix fixation system at the desired location perpendicular (90-degree angle) to the mesh or tissue and apply adequate pressure.Different types of mesh may require different amounts of counterpressure.Adjust angle and counterpressure appropriately." 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.The reported date of incident (event date) is 07-feb-2022.However, the provided lot# huhx1306 has a manufacture date of 16-nov-2023, which contradicts the event date as it precedes the manufacturing date, hence we have documented this required date field with a best estimate based on the date of awareness (21-nov-2025).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 an abdominal wall hernia surgery (laparoscopic ipom), the permafix enhanced fixation device fasteners failed to fixate and dislodged frequently.The surgeon was experienced using permafix and removed the loose fasteners from the patient's body.The procedure was completed successfully using another device.There was no patient injury.

• Brand Name: PERMAFIX 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: 23831728
• Report Number: 1213643-2025-01236
• Device Sequence Number: 5093481
• Product Code: GDW
• UDI-Device Identifier: 00801741016721
• UDI-Public: (01)00801741016721(17)260928(10)HUHX1306
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K111153
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/25/2025

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: 09/28/2026
• Device Catalogue Number: 0113120
• Device Lot Number: HUHX1306
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2025
• Initial Report FDA Received Date: 12/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/16/2023
• 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