MAUDE Adverse Event Report: ETHICON INC. GUT PL UD 18IN 3-0 S/A V-7; SUTURE, ABSORBABLE, NATURAL

Catalog Number	849G
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 needles are detaching from the suture material during use and this does not normally occur.There were no patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint #(b)(4).Date sent to the fda: 8/12/2024 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.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: ¿ please clarify how many needles were reported to be detaching from the suture? ¿ what is the lot number of each damaged product? ¿ did the event occur during one or multiple patient procedures? ¿ if multiple patient procedures, please clarify the total number of procedures, and please create a product complaint for each event and provide the respective reference number(s).¿ are any involved devices returning for evaluation? if yes, please clarify how many to products will be returned? ¿ please perform and document the follow up attempt for product return.Please document the shipment tracking number in notes or rmao sections.¿ please provide the source or name and title of external person providing answers to follow-up (external person submitting answers to sales rep or loc/bq) 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.

• Brand Name: GUT PL UD 18IN 3-0 S/A V-7
• Common Device Name: SUTURE, ABSORBABLE, NATURAL
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; calle durango #2751; ciudad juarez 32575 ; MX 32575
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 19961835
• Report Number: 2210968-2024-08350
• Device Sequence Number: 20599096
• Product Code: GAL
• UDI-Device Identifier: 10705031016309
• UDI-Public: (01)10705031016309(11)230725(17)280630(10)THMLSB
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial

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: 849G
• Device Lot Number: THMLSB
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2024
• Initial Report FDA Received Date: 08/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/25/2023
• 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