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

Model Number	SXPP1B416
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Hemorrhage/Blood Loss/Bleeding (1888)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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.(b)(4).To date it has been reported that the device will not be returned.If the device or further details are received as a later date a supplemental medwatch will be sent.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.Please provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure.Date of index surgical procedure? the diagnosis and indication for the index surgical procedure? what was the tissue condition (normal, thin, calcified, fragile, diseased)? did the wound dehis? if yes, what tissue dehisced? onset date/time of dehiscence? (# post op days).How was the dehiscence managed, if applicable? was the fixation loop secured to tissue at the initiation of suture use during the index procedure? was at least one reverse stitch performed prior to closure? what is meant by the ¿wound moved¿? when did the bleeding occur (number of days post-op)? what was the source and triggering event of bleeding? what was the volume of blood loss? how was the bleeding treated? please describe any medical/surgical intervention required for this suture event including dates and results.Did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement or during any re-operation? were there any precipitating stress factors for the suture breakage or pulling out of the tissue? did the stratafix suture break? if so, where was the break noted (termination, middle, end)? can you describe the appearance of the stratafix suture during second procedure, if applicable? what is the physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient's current status? lot number?.
Event or Problem Description
It was reported that a patient underwent a robotic total hysterectomy on an unknown date and a barbed suture was used as continuous suture on the vaginal cuff.Post-op, hemorrhage occurred.After surgery, when the patient started walking, there was blood coming from the vagina.The bleeding site was additionally sutured transvaginally.The surgeon opined that, because the bleeding occurred when the patient started walking, the surgeon thinks that when the wound moved, the bleeding occurred.The surgeon doesn¿t think that the product was related to this event directly.Because the bleeding occurred on the loop placement side, the loop might not have been properly placed.Additional information was requested.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 1/6/2023.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.Additional information was requested, and the following was obtained: after the patient was discharged from the hospital and when started walking, there was blood coming from vagina.The bleeding site was additionally sutured transvaginally.No suture breakage occurred.After an additional suturing, the patient recovered without any problem.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 1/19/2023 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.Additional information was requested, and the following was obtained: please provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure:female date of index surgical procedure?:unknown.The diagnosis and indication for the index surgical procedure? :unknown.What was the tissue condition (normal, thin, calcified, fragile, diseased)?:unknown.Did the wound dehis?:unknown.If yes, what tissue dehisced? onset date/time of dehiscence? (# post op days):unknown.How was the dehiscence managed, if applicable? :the bleeding site was additionally sutured transvaginally.Was the fixation loop secured to tissue at the initiation of suture use during the index procedure?:the surgeon think the bleeding occured possibly because he didn't secured fixation loop because bleeding occured around fixation loop.Was at least one reverse stitch performed prior to closure?:unknown.What is meant by the ¿wound moved¿?:no further information is available.When did the bleeding occur (number of days post-op)? : the bleeding occurred when the patient started walking.What was the source and triggering event of bleeding?:because the bleeding occurred when the patient started walking, the surgeon thinks that when the wound was moving, the bleeding occurred.What was the volume of blood loss?:unknown.How was the bleeding treated? :the bleeding site was additionally sutured transvaginally.Please describe any medical/surgical intervention required for this suture event including dates and results.:sutured transvaginally did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement or during any re-operation?:unknown.Were there any precipitating stress factors for the suture breakage or pulling out of the tissue?:unknown.Did the stratafix suture break? if so, where was the break noted (termination, middle, end)?:no.Can you describe the appearance of the stratafix suture during second procedure, if applicable?:unknown.What is the physician¿s opinion as to the etiology of or contributing factors to this event?: the surgeon doesn¿t think that the product was related to this event directly.What is the patient's current status?:no problem.Lot number?:unknown.

• Brand Name: SFX SPI PDS+ UNI VIO 12IN 2-0 S/A SH
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km. 8.3; san lorenzo 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 15941817
• Report Number: 2210968-2022-10126
• Device Sequence Number: 17706774
• Product Code: NEW
• UDI-Device Identifier: 30705031235896
• UDI-Public: 10705031235892
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: SXPP1B416
• Device Catalogue Number: SXPP1B416
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2022
• Supplement Date Received by Manufacturer: 12/28/2022; 01/17/2023
• Initial Report FDA Received Date: 12/08/2022
• Supplement Report FDA Received Date: 01/06/2023; 01/19/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female