MAUDE Adverse Event Report: ETHICON INC. SFX SYM PDS+ UNI VIO 18IN 0 S/A OS-6; SUTURE, SURGICAL, ABSORBABLE

Model Number	SXPP1A200
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 number: (b)(4).Date sent to the fda: 5/11/2022 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.The following information was requested, but was unavailable: please provide procedure name and date no further information is available.Please provide lot number =>no further information is available.Please provide the return status of the device(s) as it has not been received for analysis.If the device has been shipped, please provide the shipment tracking details.We regularly contact with sales rep about the device returning.No further information will be provided.Investigation summary: the product was returned for evaluation.Ethicon inc conducted a visual inspection of the sample returned.Visual analysis of the returned product revealed that one opened sample product code sxpp1a200 was received for evaluation.Upon visual inspection of the returned sample, the suture barbs were to be damaged at the tips, in addition, the fixation tab was observed to have a side broken.After further evaluation of the fixation tab crimping marks were observed on the tab possibly from a surgical device.It should be noted that a 100% inspection is performed via automotive vision system to ensure the tab is present and complete during manufacturing.The manufacturing records couldn't be reviewed as the batch number is unknown.As part of ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.This is a combination product, and the event has been reviewed for both the suture and the triclosan.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 a an unknown surgery on an unknown date and barbed suture was used.It was noticed that there was only a half of the fixation tab before use, so it was not used for the surgery.There were no patient consequences reported.Additional information was requested.

• Brand Name: SFX SYM PDS+ UNI VIO 18IN 0 S/A OS-6
• 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
• MDR Report Key: 14366290
• Report Number: 2210968-2022-03629
• Device Sequence Number: 2046596
• Product Code: NEW
• UDI-Device Identifier: 10705031227668
• UDI-Public: 10705031227668
• 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): 05/11/2022

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 Model Number: SXPP1A200
• Device Catalogue Number: SXPP1A200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2022
• Initial Report FDA Received Date: 05/11/2022
• 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