MAUDE Adverse Event Report: ETHICON INC. STFX SYM PDS+ UNI VIO 9IN 2-0 S/A V-7; SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

Catalog Number	SXPP1A424
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	01/01/2023
Type of Reportable Event	Malfunction
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, part 4 subpart b.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.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 via: were there any patient consequences? post-operative bleeding immediately after surgery.What is the procedure date (dd/mm/yyyy)? waiting on staff to provide exact date.Please provide the source or name and title of external person providing answers to follow-up (external person submitting answers to sales rep).(b)(6).A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.
Event or Problem Description
It was reported that a patient underwent a tlh procedure in 2023 and barbed suture was used.The device was used to sew the perineum.It was reported by the sales rep that post-op to the surgeon used a 2-0 stratafix symmetric (ref: sxpp1a424) for his vaginal cuff closure on a tlh procedure.He reported that after the procedure finished and patient was sent to pacu, the patient started vomiting and exerted a lot of force.As a result, the patient felt a "pop" and began to experience vaginal bleeding.The surgeon examined the patient and noticed a very small gap/weak point on the vaginal cuff.The patient did not experience a dehiscence but it was apparent that there was a break on the suture.No readmission was necessary since fortunately the patient did not experience a dehiscence.The patient experienced an adverse event.Additional information was requested.

• Brand Name: STFX SYM PDS+ UNI VIO 9IN 2-0 S/A V-7
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE
• 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: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 18093499
• Report Number: 2210968-2023-08655
• Device Sequence Number: 15134903
• Product Code: NEW
• UDI-Device Identifier: 10705031245358
• UDI-Public: 10705031245358
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: K141776
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2023

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: 09/30/2024
• Device Catalogue Number: SXPP1A424
• Device Lot Number: SLMEUC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/12/2023
• Supplement Date Received by Manufacturer: 11/11/2023
• Initial Report FDA Received Date: 11/08/2023
• Supplement Report FDA Received Date: 12/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2022
• 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