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	03/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, permafix enhanced fixation device failed to fixate the mesh.The subject device is available for evaluation, however, at this time has not been received.Based on the information available and without having the sample to evaluate, no conclusions can be made.Review of manufacturing records confirms product was manufactured to specification, with no indication of a manufacturing related cause for the event reported.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in apr, 2023.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." 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.H3 other text : not returned.
Event or Problem Description
As reported, during an incisional hernia repair procedure, the surgeon felt it was hard to pull the trigger while trying to fixate the mesh using a permafix enhanced fixation device.It was also reported that the device failed to fixate the mesh and the procedure was completed using another fixation device.There was no patient injury.
Event or Problem Description
As reported, during an incisional hernia repair procedure, the surgeon felt it was hard to pull the trigger while trying to fixate the mesh using a permafix enhanced fixation device.It was also reported that the device failed to fixate the mesh and the procedure was completed using another fixation device.There was no patient injury.
Additional Manufacturer Narrative
As reported, permafix enhanced fixation device failed to fixate the mesh.The subject device is available for evaluation, however, at this time has not been received.Based on the information available and without having the sample to evaluate, no conclusions can be made.Review of manufacturing records confirms product was manufactured to specification, with no indication of a manufacturing related cause for the event reported.To date, this is the only reported complaint for this manufacturing lot of (b)(4)units released for distribution in apr, 2023.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." addendum: this supplemental mdr is submitted to report the sample evaluation results.Evaluation of the returned sample confirms that the reported event of failure to fixate.Simulated use testing found the device did not fixate as reported.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.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.

• 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: 19115576
• Report Number: 1213643-2024-00152
• Device Sequence Number: 15229576
• Product Code: GDW
• UDI-Device Identifier: 00801741016721
• UDI-Public: (01)00801741016721
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2024

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: 02/28/2026
• Device Catalogue Number: 0113120
• Device Lot Number: HUHQ1161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2024
• Supplement Date Received by Manufacturer: 04/22/2024
• Initial Report FDA Received Date: 04/16/2024
• Supplement Report FDA Received Date: 05/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/17/2023
• 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