MAUDE Adverse Event Report: ETHICON INC. SILK BLK 10X30IN 0 NON NDL; SUTURE, NONABSORBABLE, SILK

Catalog Number	SA86G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a whole uterus and bilateral salpingectomy procedure on (b)(6) 2025 and suture was used.During the procedure, the doctor used suture to suture the surgical incision and fix the tissue during the operation.When using the suture to suture the wound, the suture was pulled multiple times and immediately broke, causing the suture to fail.The doctor immediately replaced the suture and re sutured it, which resulted in prolonged surgery time and multiple skin punctures.Patients may have an increased risk of infection or anesthesia related complications due to prolonged surgical time.Postoperative incision monitoring has been strengthened to prevent infection.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.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.The following information was requested, but unavailable: did one suture thread broke multiple times during use on the patient or multiple suture threads broke during use on the patient? * if multiple suture threads broke during use on the patient, please provide the number of sutures that broke.One suture thread broke multiple times during use on the patient how long was the delay? please specify in minutes.Was there any change in the patient¿s post-operative care due to the prolonged procedure? - were there any unexpected outcomes or complications as a result of the prolonged surgery time and the multiple skin punctures? please explain the measures taken to strength the postoperative incision to prevent infection on the patient.Was there any medical or surgical intervention performed (product removed; re-operation; re-suturing; re-closure; drainage)? if so, please specify.Was a prescription for steroids or antibiotics issued for the patient's recovery? if so, please provide the medication name, route, and dosage.Please inform the patient¿s current health status and condition.- please provide the lot number.Please refer to the event description, other information requested is unknown.The manufacturing records could not be reviewed as the batch/lot number is unknown.D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.

• Brand Name: SILK BLK 10X30IN 0 NON NDL
• Common Device Name: SUTURE, NONABSORBABLE, SILK
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.; 1000 route 202; raritan 08869
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 23490593
• Report Number: 2210968-2025-12582
• Device Sequence Number: 4695027
• Product Code: GAP
• UDI-Device Identifier: 10705031050297
• UDI-Public: 10705031050297
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/06/2025

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: SA86G
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2025
• Initial Report FDA Received Date: 11/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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