MAUDE Adverse Event Report: ETHICON INC. SFX SPI PDS+ UNI VIO 12IN 0 S/A CT-2; SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

Model Number	SXPP1B405
Medical Device Problem Codes	Break (1069); Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint (b)(4).Component code: (b)(4) device not returned.A manufacturing record evaluation was performed for the finished device batch qjbbjx, sxpp1b405 and no non-conformances were identified.To date the device has not been returned.If the device or further details are received at the 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 g/m.Events were submitted via 2210968-2021-01835, and 2210968-2021-01838.
Event or Problem Description
It was reported that the patient underwent a gynecological procedure on (b)(6) 2021 and the barbed suture was used.During the procedure, the suture frayed and broke while closing the vaginal cuff.A new suture of a different lot was used to complete the procedure.There were no adverse consequences for the patient reported.

• Brand Name: SFX SPI PDS+ UNI VIO 12IN 0 S/A CT-2
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 11388487
• Report Number: 2210968-2021-01837
• Device Sequence Number: 14388434
• Product Code: NEW
• UDI-Device Identifier: 10705031236080
• UDI-Public: 10705031236080
• Combination Product (Y/N): Y
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K150670
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/02/2021

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: 07/31/2022
• Device Model Number: SXPP1B405
• Device Catalogue Number: SXPP1B405
• Device Lot Number: QJBBJX
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2021
• Initial Report FDA Received Date: 02/26/2021
• Patient Sequence Number: 1