MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. PROXIMATE*RELOAD THICK TISSUE; STAPLE, IMPLANTABLE

Catalog Number	TRT10
Medical Device Problem Code	Structural Problem (2506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 5/9/2024.D4: batch #371a27.Investigation summary: the product was returned for evaluation.Visual inspection was conducted on the returned device.Visual analysis of the returned sample determined that the trt10 reload was received with no apparent damage and with no staple retainer present.The reload had the proximal 26 drivers up scattered along the staple line and 19 staples were noted to be missing along the cartridge.The returned cartridge reload had the swing tab in the unlocked position.No functional test was performed in order to preserve the evidence.As part of our quality process, the manufacturing records of this batch was reviewed, and the manufacturing standards were met prior to the release of this batch.No conclusion could be reached on what caused the staples falling out of the reload as the reload was received unlocked.It should be noted that all devices are inspected 100% for staple presence by an automated vision system, and are visually inspected 100% as a final check.In addition, at finished goods the devices are visually inspected based on a sample.As part of ethicon endo surgery¿s quality process, all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device batch number 371a27, and no non-conformances were identified.The lot#560a17 history records were reviewed and certified by external manufacturing that the manufacturing criteria were met prior to the release of the equipment.The certificate records are accessible through external manufacturing.Additional information was requested, and the following was obtained: 1.Could you please clarify if there were any patient consequences? unknown.2.Could you please clarify if was any change in the post-operative care of the patient as a result of the event? unknown.
Event or Problem Description
It was reported that during an unknown procedure the pins of the trt was already falling out from the reloads.

• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; PR ; 3035526892
• MDR Report Key: 19280709
• Report Number: 3005075853-2024-03523
• Device Sequence Number: 7702987
• Product Code: GDW
• UDI-Device Identifier: 10705036003236
• UDI-Public: 10705036003236
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K020779
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/09/2024

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 Catalogue Number: TRT10
• Device Lot Number: 560A17
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/06/2024
• Initial Report FDA Received Date: 05/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2021
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown