MAUDE Adverse Event Report: ETHICON INC. ETHILON SUTURE 30IN(75CM) 4-0 BLK; SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE

Model Number	F2435H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2022
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.During the procedure, the needle pulled off from the thread the same issue happened on several devices from the same lot.There were no patient consequences 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 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.The following additional information was requested: when was the needle detached/pulled off from the suture (in the package, during removal from package, during handling prior to use on patient or during use on the patient)? please specify was there any adverse consequence associated with the patient? please perform and document the follow up attempt for product return.Please document the shipment tracking number in notes or rmao sections.- it was reported that the same issue happened on several devices from the same lot, please specify: 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).If this event occurred in multiple procedures, please create a product complaint for each event and provide the respective reference number(s).The following information was obtained: there was no patient consequence but the surgeon encountered the issue 3 times.He kept only one impacted device, the last which was used, so it is available for analysis.The needle pulled off the strand during the suture, so during the analysis, be careful, because the needle is dirty.The surgeon soaked it in alcohol for two hours, but still be careful.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 related reports: 2210968-2022-10696, & 2210968-2022-10697.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 01/19/2023.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.Additional information: h6, d4, h4.Additional information was requested, and the following was obtained via: new information received from the customer related to the (b)(4) on (b)(6) 2023 : regarding the number of patients involved, there were 3.There was no harm to the patients but it happened 3 times 2 other complaints were recorded : the (b)(6) are related.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 3/6/2023.H3 investigational summary: the product was returned to ethicon for evaluation.Visual inspection was conducted on the returned device.Visual analysis of the returned sample determined that one empty labeled winding former, one detached needle and one suture piece that pertains to product code f2435h were returned for analysis.After investigation of the sample, the swage and attachment area was not as expected; since the hit of the stake was on the edge of the swage area of the needle, causing the suture to be severely cut due to an incorrect swage resulting in breakage suture.Based on the information currently available, an incorrect swage issue was identified during the investigation of the sample received.This product issue will be addressed through the ethicon quality system.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post-market surveillance.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.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 1/23/2023.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.Additional information received: information was received that there were 3 patients involved.2 other complaints were recorded : the (b)(4) and (b)(4) are related.As it was determined that there were 3 patients and not just 1, with one suture each,.

• Brand Name: ETHILON SUTURE 30IN(75CM) 4-0 BLK
• 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
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 16060559
• Report Number: 2210968-2022-10695
• Device Sequence Number: 19335116
• Product Code: GAR
• UDI-Device Identifier: 10705031239036
• UDI-Public: 10705031239036
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/06/2023

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: F2435H
• Device Catalogue Number: F2435H
• Device Lot Number: RPBCRT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2022
• Supplement Date Received by Manufacturer: 01/03/2023; 01/23/2023; 02/16/2023
• Initial Report FDA Received Date: 12/28/2022
• Supplement Report FDA Received Date: 01/19/2023; 01/23/2023; 03/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/13/2021
• 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): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown