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

Model Number	SXPP1B415
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).This is a combination product, and the event has been reviewed for both the suture and the triclosan.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Additional information was requested and the following was obtained: was there any change in the patient¿s post-operative care due to the prolonged procedure? no change in post op care.Was there any adverse consequence associated with the patient? no.Device return status? not available.To date it has been reported that the device will not be returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Trade name - irgacare®, active ingredient(s) ¿ triclosan, dosage form ¿ suture/solid/parenteral, strength ¿ = 2360 ug/m.
Event or Problem Description
It was reported that a patient underwent a gastric by-pass procedure on (b)(6) 2021 and suture was used.While closing the opening of the stoma, the spirals in the body of the suture were not grasping enough tissue and at the end of the second closing passage, the suture just reopened partially.The procedure was completed successfully with a 5 minute delay.There were no adverse patient consequences.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # : (b)(4).Date sent to the fda: 10/6/2021.A manufacturing record evaluation was performed for the finished device batch qgbdkl, lot number sxpp1b41513 and no non-conformances were identified.Additional information: d4, h4.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.

• Brand Name: SFX SPI PDS+ UNI VIO 6IN 2-0 S/A SH
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12253137
• Report Number: 2210968-2021-06856
• Device Sequence Number: 19639125
• Product Code: NEW
• UDI-Device Identifier: 10705031235885
• UDI-Public: 10705031235885
• Combination Product (Y/N): Y
• Initial Reporter Country: IT
• 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,Followup
• Report Date (Section B): 10/06/2021

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: 05/31/2022
• Device Model Number: SXPP1B415
• Device Catalogue Number: SXPP1B415
• Device Lot Number: QGBDKL
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/05/2021
• Supplement Date Received by Manufacturer: 09/28/2021
• Initial Report FDA Received Date: 07/30/2021
• Supplement Report FDA Received Date: 10/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1