MAUDE Adverse Event Report: ETHICON INC. SILK SUTURE 30"(75CM) 3-0 BLK; SUTURE, NONABSORBABLE, SILK

Model Number	C017D
Medical Device Problem Code	Break (1069)
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 in 2022 and suture was used.During the procedure, the suture is easy to break during the suturing process.No adverse patient consequences were 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.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 Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 1/31/2023.H6 component code: g07002 no device problem found.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.H3 investigational summary: the product was returned to ethicon for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample revealed that one empty opened ow and one winding former with seven strands, one detached needle, and one undispensed suture that pertained to product code c017d were returned for analysis.The product code is multistrand and each packet contains eight strands single armed.In order to evaluate the conditions of the returned sample, no defects were detected.The swage and attachment area were noted to be as expected.The sutures were dispensed without problems and examined along of the strands to detect any issue related to damaged or breakage suture and no defects were observed during evaluation.The functional test was performed using instron equipment, and the pull force and tensile strength were above the minimum requirements.During the visual inspection of the detached needle, the swage and attachment area were as expected.The suture was examined, and correct insertion marks were observed; however, the force used to detach the needle from the suture could not be determined.As part of our quality process, the manufacturing records of this lot-serial number were reviewed, and the manufacturing standards were met prior to the release of this batch.It should be noted that as part of our quality process, each batch is randomly inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.Additional complaint information monitoring for potential safety signals is 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.

• Brand Name: SILK SUTURE 30"(75CM) 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
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 16039560
• Report Number: 2210968-2022-10589
• Device Sequence Number: 15259983
• Product Code: GAP
• UDI-Device Identifier: 10705031023499
• UDI-Public: 10705031023499
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2023

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: 06/30/2026
• Device Model Number: C017D
• Device Catalogue Number: C017D
• Device Lot Number: RHBDQC
• 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: 11/29/2022
• Supplement Date Received by Manufacturer: 01/17/2023
• Initial Report FDA Received Date: 12/22/2022
• Supplement Report FDA Received Date: 01/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/21/2021
• 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