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 Codes	Material Integrity Problem (2978); Migration (4003)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Hemorrhage/Blood Loss/Bleeding (1888); Pocket Erosion (2013); Scar Tissue (2060)
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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Trade name - irgacare®.Active ingredient(s) ¿ triclosan.Dosage form ¿ suture/solid/parenteral.Strength ¿ 2360 g/m.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.Additional information was requested and the following was obtained: the customer has recovered unused units of the lot number qdbell form the impacted operating room.The customer is not sure that this is the impacted lot.Additional information received from the customer : i observed at the end of 2020 and the beginning of 2021, when i saw again one month after the hysterectomy by laparoscopy, the patients in whom i had performed the vaginal sutures with stratafix, that the thread was visible vaginally, it appeared to be excluded from the vaginal suture.There was no revision, new intervention or delayed healing, but this had not happened before, i thought the thread was resorbed locally.Has the surgeon observed any defect or abnormality in the suture before, during or after its use in the patient? after its use unabsorbed thread and released from the vaginal suture.Was medical or surgical intervention necessary (product withdrawn, reoperation, steroids, antibiotics, prescription drugs)? if yes which one ? no.Was medical / surgical intervention necessary due to postoperative bleeding? no.Could you please provide the initial date of the procedure, as well as the date the patients were seen? several patients between 2020 and 2021 at 1 month post-intervention related medwatch reports: 2210968-2021-01969, 2210968-2021-01970.
Event or Problem Description
It was reported that a patient underwent a hysterectomy on an unknown date and barbed suture was used.The thread did not resorbed and was rejected by the body when seen by surgeon 1 month after the surgery.The impact to the wound was bad scarring and the duration of post-op bleeding.No serious consequences for the patient.Additional information was requested.
Additional Manufacturer Narrative
(b)(4).Date sent to fda: 03/29/2021.A manufacturing record evaluation was performed for the finished device batch qdbell, (b)(6) and no non-conformances were identified.This is a combination product, and the event has been reviewed for both the suture and the triclosan.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.Trade name - irgacare®.Active ingredient(s) ¿ triclosan.Dosage form ¿ suture/solid/parenteral.Strength ¿ = 2360 g/m.Related medwatch reports: 2210968-2021-01969, 2210968-2021-01970, 2210968-2021-01971.

• 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.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 11408590
• Report Number: 2210968-2021-01971
• Device Sequence Number: 11648986
• Product Code: NEW
• UDI-Device Identifier: 10705031235885
• UDI-Public: 10705031235885
• 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,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/09/2021

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: 03/31/2022
• Device Model Number: SXPP1B415
• Device Catalogue Number: SXPP1B415
• Device Lot Number: QDBELL
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/09/2021
• Supplement Date Received by Manufacturer: 03/29/2021; 03/31/2021
• Initial Report FDA Received Date: 03/03/2021
• Supplement Report FDA Received Date: 03/29/2021; 03/31/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1