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

Model Number	SXPP1A402
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a wound closure procedure on an unknown date and barbed suture was used.During the procedure, end tab of suture was defective and unable to use.There were no patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint number: (b)(4).(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.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent: was there any adverse consequence associated with the patient? what is the tab of suture defect? please provide more details.Please provide the lot number: device return status: 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 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 ug /m.

• Brand Name: SFX SYM PDS+ UNI VIO 18IN 0 S/A CTX
• 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: 14246209
• Report Number: 2210968-2022-03129
• Device Sequence Number: 11867467
• Product Code: NEW
• UDI-Device Identifier: 10705031218741
• UDI-Public: 10705031218741
• Combination Product (Y/N): Y
• Initial Reporter State: MO
• Initial Reporter Country: US
• 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: Other,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/28/2022

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: SXPP1A402
• Device Catalogue Number: SXPP1A402
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2022
• Initial Report FDA Received Date: 04/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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