MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN RELIATACK; STAPLE, IMPLANTABLE

Model Number	RELTACK4XDPTSW
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, during a laparoscopic ventral hernia repair, when the surgeon was trying to secure the mesh into place.The surgeon noted that the tacker was not firing appropriately as the tacks remained partially in the shaft of the device and they were not fully engaging the tissue.The mesh was unable to be secured with the device so a different tacker was used to resolve the issue.The surgeon had to spend an additional 30 minutes to the surgical time trying to get the tacker to work, removing the inadequately secured tacks, then re-tacking the mesh with a different device.
Additional Manufacturer Narrative
Uf/importer rpt num: (b)(4).Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: RELIATACK
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer (Section G): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 19194064
• Report Number: 1219930-2024-01885
• Device Sequence Number: 7640970
• Product Code: GDW
• UDI-Device Identifier: 10884521726383
• UDI-Public: 10884521726383
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K151659
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 04/26/2024

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: 12/31/2025
• Device Model Number: RELTACK4XDPTSW
• Device Catalogue Number: RELTACK4XDPTSW
• Device Lot Number: N3C0204Y
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2024
• Initial Report FDA Received Date: 04/26/2024
• Date Device Manufactured: 03/07/2023
• 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
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 88 KG