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	01/14/2026
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during an incisional hernia repair without obstruction, the permafix enhanced fixation device fasteners failed to fixate.It was reported that only a partial tack was deployed in the area of fixation, which involved soft tissue.The procedure was completed successfully using an another device.There was no patient injury.
Additional Manufacturer Narrative
As reported, the permafix enhanced fixation device failed to fixate the fasteners.The evaluation of the device could not reproduce the reported event that the device failed to fixate.The device functioned as intended during functional and simulated use testing.No manufacturing anomalies were found.A review of the manufacturing records was performed and found the lot was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units.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.

• 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: 24209110
• Report Number: 1213643-2026-00062
• Device Sequence Number: 9635227
• Product Code: GDW
• UDI-Device Identifier: 00801741016721
• UDI-Public: (01)00801741016721(17)270828(10)HUJV1801
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K111153
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/20/2026

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: 0113120
• Device Lot Number: HUJV1801
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2026
• Initial Report FDA Received Date: 01/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/30/2024
• 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