MAUDE Adverse Event Report: ETHICON INC. SILK BLK 18IN USP3-0; SUTURE, NONABSORBABLE, SILK

Model Number	W328H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a plastic surgery in 2023 and suture was used.During the procedure, both complaint products broke during a plastic surgery case in the hospital.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).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.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.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.Was there any adverse consequence associated with the patient? a manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Events reported via: 2210968-2023-01287, 2210968-2023-01288 and 2210968-2023-01289.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 3/23/2023.Additional information was requested, the following was obtained: there was no adverse consequences to the patients.The following information was requested: please confirm one patient was involved for this event.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.Related reports: 2210968-2023-01287, 2210968-2023-01288, 2210968-2023-01289, 2210968-2023-01290.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 4/27/2023.The following additional information was requested: according to the additional information received, another box of the vicryl rapide had an issue.Please provide the product code and lot number for the additional box.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.Related reports: 2210968-2023-01287, 2210968-2023-01288, 2210968-2023-01289, 2210968-2023-01290.
Additional Manufacturer Narrative
Product complaint #(b)(4).Date sent to the fda: 4/27/2023.Additional information was requested, the following was obtained: for the vicryl rapide the issue happened of a 3 cases that is when they identified it as a problem.The same with the other suture over 2 procedures.And a couple of sutures were used from each box as well for rapide they changed the box and still had same issues.The other suture we changed box and didn't receive further issues 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.Related reports: 2210968-2023-01287, 2210968-2023-01288, 2210968-2023-01289, 2210968-2023-01290.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 5/31/2023.Additional information was requested, the following was obtained: product code: v2910h lot : rkbcxjx0.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.Related reports: 2210968-2023-01287, 2210968-2023-01288, 2210968-2023-01289, 2210968-2023-0129.

• Brand Name: SILK BLK 18IN USP3-0
• 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
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 16413784
• Report Number: 2210968-2023-01290
• Device Sequence Number: 12198083
• Product Code: GAP
• UDI-Device Identifier: 10705031202290
• UDI-Public: 10705031202290
• Combination Product (Y/N): N
• Initial Reporter Country: ZI
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 05/31/2023

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: 02/28/2025
• Device Model Number: W328H
• Device Catalogue Number: W328H
• Device Lot Number: QCBBSQ
• 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: 02/12/2023
• Supplement Date Received by Manufacturer: 03/01/2023; 04/11/2023; 04/11/2023; 05/29/2023
• Initial Report FDA Received Date: 02/21/2023
• Supplement Report FDA Received Date: 03/23/2023; 04/27/2023; 04/27/2023; 05/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2020
• 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