MAUDE Adverse Event Report: ETHICON INC. SFX SPI PDS+ UNI VIO 12IN 2-0 S/A UR-6; SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

Model Number	SXPP1B419
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2021
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.Trade name - irgacare®.Active ingredient(s) ¿ triclosan.Dosage form ¿ suture/solid/parenteral.Strength = 2360 g/m.Attempts are being made to receive a device.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.Attempts are being made to clarify 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.Please clarify how the anastomosis repair was done? was the repair preformed during the same procedure? please clarify what do you mean by "several lot impacted" ? were multiple devices used for this procedure with the same issue or this issue happened during the procedure of multiple patients? event day? lot? device status? if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Events were submitted via 2210968-2021-02136.
Event or Problem Description
It was reported that the patient underwent an anastomosis procedure in 2021 and the barbed suture was used.During surgery, anastomosis had to be repair because of grip deficiency of the barbed suture.The procedure time was extended.No further information provided.

• Brand Name: SFX SPI PDS+ UNI VIO 12IN 2-0 S/A UR-6
• 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: 11445984
• Report Number: 2210968-2021-02135
• Device Sequence Number: 4611327
• Product Code: NEW
• UDI-Device Identifier: 10705031235915
• UDI-Public: 10705031235915
• Combination Product (Y/N): Y
• Initial Reporter Country: FR
• 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,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/11/2021

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 Model Number: SXPP1B419
• Device Catalogue Number: SXPP1B419
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2021
• Initial Report FDA Received Date: 03/09/2021
• Patient Sequence Number: 1