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

Catalog Number	K945G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a dental procedure on (b)(6) 2025 and suture was used.During the procedure, the practitioner reports a rupture of the suture in the mouth in a patient.This incident follows a first report made in august which was not followed up due to insufficient information: lot number not communicated, lack of details on the nature of the incident, and impossibility of contacting the customer.During the call of (b)(6) 2025, the practitioner indicates that a new incident of mouth breakage has occurred, in addition to the three ruptures already mentioned in the initial complaint.He clarified that all the wires concerned, for both alerts, came from the same lot: 107hpl.The collection of the products could not be organized, the practitioner no longer having the articles concerned.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).H6 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.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 via: please provide an answer for each case: (b)(4)= (b)(6) 2025 - external reference : (b)(4).(b)(4) = (b)(6) 2025 - external reference : (b)(4).- did the reported issue contribute to any patient adverse consequences? - please provide the source or name of person providing answers to follow-up questions: (b)(6) 2025, (b)(4) created for this event (b)(6) 2025 for (b)(4) (please update with the right event date), (b)(6) 2025 for (b)(4) (please update with the right event date).The incidents did not require medical assistance.The impacted quantity of parts is 5, across 3 surgeries.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.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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 11/24/2025.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: d4, 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.-SAN LORENZO PR; road 183, km 8.3; san lorenzo PR 00754
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 23324264
• Report Number: 2210968-2025-12002
• Device Sequence Number: 15939800
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup

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: 09/24/2025
• Supplement Date Received by Manufacturer: 10/30/2025
• Initial Report FDA Received Date: 10/17/2025
• Supplement Report FDA Received Date: 11/24/2025
• 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