MAUDE Adverse Event Report: ETHICON INC. SFX SYM PDS+ UNI VIO 18IN 1 S/A CTXB; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	SXPP1A300
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
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.Trade name - irgacare® active ingredient(s) ¿ triclosan dosage form ¿ suture/solid/parenteral strength ¿ = 2360 g/m.H3 investigation summary: the product was returned for evaluation.Visual inspection was conducted on the returned device.The returned sample revealed that it was received, one open sample that pertain to the product code sxpp1a300.During the visual assessment of the needle suture, the suture was examined, body fluids and damage at some barbs were noted and both sides of the fixation tab were broken.It should be noted that a 100% inspection is performed via the automotive vision system to ensure the tab/stopper, barbs and core is present and complete during manufacturing.As part of the ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.The instructions for use contain the following caution: to seat the fixation tab; pull the device through the tissue to gently seat the fixation tab against the tissue.The fixation tab should be seated above the tissue plane and be visible.Do not exert additional force on the fixation tab or device.Moving toward the apex of the incision, take a pass in the intact tissue perpendicular to the initial pass to lock the stitch.Multiple passes are acceptable.Pull gently on the device to take up any slack.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and barbed suture was used.It was reported by a sales rep that, before use it was found that the fixation tab was already broken.During the visual assessment of the returned needle suture, the suture was examined, body fluids and damage at some barbs were noted and both sides of the fixation tab were broken.No adverse patient consequences were reported.Additional information was requested.

• Brand Name: SFX SYM PDS+ UNI VIO 18IN 1 S/A CTXB
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; avenida de las torres 7125; col salvacar; cuidad juarez ; MX
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 17486702
• Report Number: 2210968-2023-05709
• Device Sequence Number: 12730735
• Product Code: NEW
• UDI-Device Identifier: 10705031219359
• UDI-Public: 10705031219359
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K113004
• 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
• Report Date (Section B): 08/09/2023

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 Catalogue Number: SXPP1A300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2023
• Initial Report FDA Received Date: 08/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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