MAUDE Adverse Event Report: COVIDIEN SURGICAL RELIATACK; STAPLE, IMPLANTABLE

Model Number	RELTACK4XDPT
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
According to the reporter, during the laparotomy with abdominal incisional hernia repair, when the mesh was placed, an attempt was made to secure the mesh.The tack was fired, but the handle was unusually hard, and the tack did not come off the mesh.Several more shots were performed after that, but due to the same issue, another type of tacker was used without any problems.There was no patient injury.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted one instrument, two eight tack reloads and one five tack reload.An eight tack reload was returned attached to the instrument.The other eight and five tack reloads were returned within their shipping wedges.Inspection of the attached reload noted it to be out of time, only showing one bar in the inspection window.With the reload removed, the instrument was noted to be out of time as well.Functional testing found that the articulation knob was rotated and the instrument articulated without issue.The instrument handle was actuated and the timing of the instrument was reset.One of the returned unused reloads was attached to the instrument without issue and the shipping wedge removed.The instrument was then applied to test media where difficulty was noted upon actuation of the instrument handle.A loud crunching sound was heard upon actuation of the handle and the tack did not deploy from the reload, partially engaging into the test media.Upon disassembly of the handle, damage to the spur gear was noted.It was reported that the tack did not come off the mesh.The reported issue was confirmed.The most likely cause could not be established from the information available.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.A secondary review of the device history records found no potentially contributing factors.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 SURGICAL; 60 middletown ave; north haven CT 06473
• Manufacturer (Section G): COVIDIEN SURGICAL; 60 middletown ave; north haven CT 06473
• Manufacturer Contact: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 23033711
• Report Number: 1219930-2025-04039
• Device Sequence Number: 13216603
• Product Code: GDW
• UDI-Device Identifier: 10884521202429
• UDI-Public: (01)10884521202429(17)280131(10)N5C2162Y
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2025

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 Model Number: RELTACK4XDPT
• Device Catalogue Number: RELTACK4XDPT
• Device Lot Number: N5C2162Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2025
• Supplement Date Received by Manufacturer: 11/25/2025
• Initial Report FDA Received Date: 09/11/2025
• Supplement Report FDA Received Date: 12/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/17/2024
• 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
• Patient Sex: Unknown