MAUDE Adverse Event Report: ETHICON INC. STFX SYM PDS+ UNI VIO 24IN 1 S/A CT-1; SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

Model Number	SXPP1A443
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).This is a combination product, and the event has been reviewed for both the suture and the triclosan.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.Additional information was requested and the following was obtained: what do you mean by "surgeon tried a second time with the same suture strand" did you mean same product code or with the exact suture that result broken?: yes, the same exact suture was utilized.The fixation tab ripped through the fascia and the surgeon attempted a second time with the same suture.Did two devices present "fixation pad was ripping" or just one? please confirm.: it was a single strand of stratafix symmetric.What is the lot number?: lot # tamblc.Trade name: irgacare®, active ingredient(s): triclosan, dosage form: suture/solid/parenteral, strength: = 2360 g/m.
Event or Problem Description
It was reported that a patient underwent an unknown gynecological procedure on (b)(6) 2023 and barbed suture was used.During facia closure, the fixation pad was ripping through the facia.Surgeon tried a second time with the same suture strand with the same outcome.A competitor¿s suture was used to complete the procedure.There were no adverse consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # = > (b)(4) this is a combination product, and the event has been reviewed for both the suture and the triclosan.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.Additional information: d4, h4, h6 a manufacturing record evaluation was performed for the finished device batch, and no non-conformances were identified.

• Brand Name: STFX SYM PDS+ UNI VIO 24IN 1 S/A CT-1
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; avenida de las torres 7125; col salvacar; ciudad juarez 32604 ; MX 32604
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 16600249
• Report Number: 2210968-2023-01996
• Device Sequence Number: 7324887
• Product Code: NEW
• UDI-Device Identifier: 10705031245280
• UDI-Public: 10705031245280
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• 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
• 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 Expiration Date: 12/31/2024
• Device Model Number: SXPP1A443
• Device Catalogue Number: SXPP1A443
• Device Lot Number: TAMBLC
• 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: 02/24/2023
• Supplement Date Received by Manufacturer: 04/20/2023
• Initial Report FDA Received Date: 03/23/2023
• Supplement Report FDA Received Date: 04/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/04/2023
• 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