MAUDE Adverse Event Report: ETHICON INC. ETHILON 30IN 2-0 BLK S/A FSLX; SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE

Catalog Number	1674BH
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional information was requested, and the following was obtained: please provide information requested below for each patient/event.Were there patient consequences? if yes, please specify.No.What is the procedure name(s) and date(s)? none provided.Can you identify the lot numbers and product code of the product that was used? product code: 1674bh, lot number: 1028eh.How many devices demonstrated the alleged deficiency? number of sutures affected not specified.Was told ¿several¿.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, or its employees that the report constitutes an admission that the product, ethicon, 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.
Additional Manufacturer Narrative
Product complaint # (b)(4).H6.Component code: g07002 - device not returned.Attempts have been made to retrieve the device.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.The single complaint was reported with multiple events.There are no additional details regarding the additional events.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.It was reported that "¿suture was breaking.Happened many times with this lot." - please confirm the number of patients affected by this alleged deficiency? - have any of these events been previously reported to ethicon? if so, provide the respective reference number(s).Please provide information requested below for each patient/event.- were there patient consequences? if yes, please specify.- what are the procedure name(s) and date(s)? - can you identify the lot numbers and product code of the product that was used? - how many devices demonstrated the alleged deficiency? a manufacturing record evaluation was performed for the finished device batch and no non-conformances were identified.This report is being submitted pursuant to the provisions of 21 cfr part 803, part 4 subpart b.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, or its employees that the report constitutes an admission that the product, ethicon, 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.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and a suture was used.The suture was breaking.This happened many times with this lot.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint #(b)(4).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, or its employees that the report constitutes an admission that the product, ethicon, 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.Additional information: h6 additional information was requested, and the following was obtained: review email attached for additional information stating.Thank you for the follow up.Unfortunately, no further information has been provided with follow up.The affected box has been shipped with the box provided.It was reported that "¿suture was breaking.Happened many times with this lot." no patient consequences were reported to the rep.

• Brand Name: ETHILON 30IN 2-0 BLK S/A FSLX
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE
• 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
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 21642623
• Report Number: 2210968-2025-02945
• Device Sequence Number: 18033539
• Product Code: GAR
• UDI-Device Identifier: 10705031240964
• UDI-Public: (01)10705031240964(17)290630(10)1028EH
• 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,Followup,Followup
• Report Date (Section B): 03/21/2025

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 Catalogue Number: 1674BH
• Device Lot Number: 1028EH
• 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: 02/21/2025
• Supplement Date Received by Manufacturer: 02/26/2025; 03/19/2025
• Initial Report FDA Received Date: 03/19/2025
• Supplement Report FDA Received Date: 03/19/2025; 03/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/18/2024
• 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