MAUDE Adverse Event Report: ETHICON INC. MCRYL+ UD 27IN 4-0 S/A SH; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	MCP415H
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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.The issue of fraying suture occurred.There were no adverse patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Component code: g07002 - device not returned.This is a combination product, and the event has been reviewed for both the suture and the triclosan.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.Additional information was requested and the following was obtained: in event description mention "we are having fraying issues" could you please clarify if there are more than one procedures involved? if yes please confirm below information: yes.Were these cases previously reported to ethicon? no.If yes, please provide a complaint reference number.If no, please create additional complaint files and provide the reference number.(b)(6) 2023 for lot: sgmjdz.If the issue occurred in this single procedure, could you please clarify how many times occurred this issue? 3 times.Could you please clarify if did any patient/s suffered from any signs or consequences due to the issue? please provide more information unknown, according to circulating team.Did the 36 devices indicated in product involved, present the fraying issue or are just samples? there was 3each found that had fraying issues in that one day (b)(6) 2023 out of the 36.But, the circulating team informed me that this fraying issue occurred many times prior to this incident.I don¿t have any used sutures available to provide you.I do have the remaining inventory of 1 full unopened box and 1 box with 3 each left.Please let me know if you would like me to return them to you.My team does not want to use them as they feel there may be more result of fraying and does not want the surgeons to get upset.Please perform and document the follow up attempt for product return.Please document the shipment tracking number in notes or rmao sections.Can you please clarify what is this? a manufacturing record evaluation was performed for the finished device batch, and no non-conformances were identified.Trade name - irgacare®.Active ingredient(s) ¿ triclosan.Dosage form ¿ suture/solid/parenteral.Strength ¿ 2360 g/m.

• Brand Name: MCRYL+ UD 27IN 4-0 S/A SH
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; avenida de las torres 7125; col salvacar; cuidad juarez ; MX
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 16625210
• Report Number: 2210968-2023-02134
• Device Sequence Number: 12156891
• Product Code: GAM
• UDI-Device Identifier: 10705031046474
• UDI-Public: 10705031046474
• Combination Product (Y/N): Y
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K050845
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/27/2023

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 Expiration Date: 05/31/2024
• Device Model Number: MCP415H
• Device Catalogue Number: MCP415H
• Device Lot Number: SGMJDZ
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2023
• Initial Report FDA Received Date: 03/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2022
• 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