MAUDE Adverse Event Report: ETHICON INC. SILK SUTURE 18"(45CM) 3-0 BLK; SUTURE, NONABSORBABLE, SILK

Model Number	C013D
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).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.Additional information was requested, and the following was obtained: was needle removed from the patient? yes.Any additional tissue dissection damage due to searching for needle? no.Event related to mw # 2210968-2022-02804.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.
Event or Problem Description
It was reported that a patient underwent a lap hernia repair procedure on 3/28/2022 and suture was used.The needle and suture were easy to separate.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
(b)(4).Date sent to fda: 05/18/2022.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.H3 analysis summary: ten packets of product code c013d were returned to ethicon for analysis with the packaging closed.Upon initial inspection, of the samples, no external damages were observed on the packets.In order to evaluate the conditions of the returned samples, the ten packets were opened, and no defects were detected.The swage and attachment area was noted to be as expected.The sutures were dispensed without problems and examined along the strand to detect any issues related to no defects observed during evaluation.Functional test was performed, and the pull force meet requirements.The device performed without any defect noted.A manufacturing record evaluation was performed for the finished device batch, and no non-conformances were identified.H6 component code: g07002 - device samples.Related events captured via 2210968-2022-02804 and 2210968-2022-02805.

• Brand Name: SILK SUTURE 18"(45CM) 3-0 BLK
• 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 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 14163231
• Report Number: 2210968-2022-02805
• Device Sequence Number: 5608985
• Product Code: GAP
• UDI-Device Identifier: 10705031023420
• UDI-Public: 10705031023420
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2022

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: 08/31/2026
• Device Model Number: C013D
• Device Catalogue Number: C013D
• Device Lot Number: RKBCKT
• 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: 03/27/2022
• Supplement Date Received by Manufacturer: 04/27/2022
• Initial Report FDA Received Date: 04/20/2022
• Supplement Report FDA Received Date: 05/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/10/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown