MAUDE Adverse Event Report: ETHICON INC. SILK SUTURE 30"(75CM) 2-0 BLK; SUTURE, NONABSORBABLE, SILK

Catalog Number	C016D
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and suture was used.It was reported that the suture becomes knotted and needles are popping off when pulling out of suture packaging.There was no patient harm.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 4/15/2024.H6 component code: g07002 - device not returned this report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.The single complaint was reported with multiple events.There are no additional details regarding the additional events.Additional information was requested, the following was obtained: it was reported that the suture becomes knotted and needles are popping off when pulling out of suture packaging.What is the total number of products involved in this event? did the event occur during one or multiple patient procedures? what is the total number of procedures? have any of these events been previously reported to ethicon? if so, provide the respective reference number(s).-device return status.Please document the shipment tracking number: please provide the source or name of person providing answers to follow-up questions: all of the 2-0 silk c016d packages do this.It occurs on every case that we use the 2-0 silk packages.It probably occurs 20 times a month.There was one other complaint submitted on this item.Product was shipped back last thursday 4/4 (b)(6) - cvor manager.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Related reports: 2210968-2024-04282, 2210968-2024-04283, 2210968-2024-04284, 2210968-2024-04285, 2210968-2024-04286, 2210968-2024-04287, 2210968-2024-04288, 2210968-2024-04289, 2210968-2024-04290, 2210968-2024-04291, 2210968-2024-04296, 2210968-2024-04305, 2210968-2024-04304, 2210968-2024-04298, 2210968-2024-04299, 2210968-2024-04301, 2210968-2024-04302, 2210968-2024-04303.

• Brand Name: SILK SUTURE 30"(75CM) 2-0 BLK
• Common Device Name: SUTURE, NONABSORBABLE, SILK
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km 8.3; san lorenzo PR 00754 ; * 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 19106155
• Report Number: 2210968-2024-04295
• Device Sequence Number: 7268543
• Product Code: GAP
• UDI-Device Identifier: 10705031023475
• UDI-Public: 10705031023475
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K946173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/15/2024

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: C016D
• Device Lot Number: TLBKMD
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2024
• Initial Report FDA Received Date: 04/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2023
• 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 Sex: Unknown