MAUDE Adverse Event Report: ETHICON INC. SILK BLK 18IN 4-0 S/A V-4; SUTURE, NONABSORBABLE, SILK

Catalog Number	K945G
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4) date sent to the fda: 11/7/2025.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.Additional information was requested; the following was obtained: what is the lot number of the suture involved in 21-aug-2025 event? this is the same lot number: 107hpl.What was the name of the procedure? the care as communicated by the practitioner "implantology session" please clarify did the needle detached/pulled off from the suture, did the suture break, or did both issue occurred over the same suture? both events occurred: ¿breakage of the thread or/and thread/needle junction during suturing during implant surgery.Please clarify when did the alleged deficiency occur (in the package, during removal from package, during handling prior to use on patient or during use on the patient)? please specify the incident occurred during the treatment ¿in the process of suturing¿ did the needle fall into the patient? if yes, was the needle piece removed from the patient during the same procedure? no what was used to complete the procedure? suture + needle.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.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2025 and suture was used.The practitioner describes breakages of the thread and/or the thread/needle junction during suturing in the implant surgery.The incident occurred during the first use of the product.The practitioner has experience with the use of this product.There were no patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 12/12/2025.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.Additional information: h6.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.

• Brand Name: SILK BLK 18IN 4-0 S/A V-4
• Common Device Name: SUTURE, NONABSORBABLE, SILK
• 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: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 23499022
• Report Number: 2210968-2025-12600
• Device Sequence Number: 18368780
• Product Code: GAP
• UDI-Device Identifier: 10705031044753
• UDI-Public: (01)10705031044753(17)300331(10)107HPL
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Report Date (Section B): 11/07/2025

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: K945G
• Device Lot Number: 107HPL
• 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: 10/14/2025
• Supplement Date Received by Manufacturer: 11/16/2025
• Initial Report FDA Received Date: 11/07/2025
• Supplement Report FDA Received Date: 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/04/2025
• 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