MAUDE Adverse Event Report: ETHICON INC. SFXSPI PDS+ UNI VIO 6IN 0 SA CT-1; SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

Catalog Number	SXPP1B406
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Wound Dehiscence (1154)
Date of Event	05/07/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent a robotic hysterectomy with bilateral salpingectomy, right oophorectomy, extensive excision of endometriosis and left ureterolysis on (b)(6) 2025 and barbed suture was used.At around 6 week post op she began walking around as she had in the past as she was doing so well.Denies intercourse or vaginal bleeding.Upon cuff check, however, it was noted to be a ~1cm opening at the right apex.She was given the opportunity to have this observed vs surgical repair and she has chosen the latter.The patient had to be re operated on (b)(6) 2025.The whole piece of barbed suture came out/off leaving a hole behind.The patient had a vaginal cuff dehiscence.The hole was repaired with a different type of suture.No special conditions or diabetes that would affect healing.The patient works as a mail carrier and would like to be certain that she has healed well prior to going back to work.Patient largely denies pelvic or abdominal pain.Denies nausea vomiting, fevers, or chills.Additional information was requested.
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.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.H6 component code: g07002 device not returned.D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.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: procedure: repair of vaginal cuff findings: normal external genitalia.The vaginal vault was grossly normal without evidence of vaginal bleeding or discharge.No evidence of infection.There was a ~1cm denuded opening observed at the right (patient¿s left) apex.There was no evidence of full dehiscence.There was n ~3.5cm segment of prior barbed suture material that was removed.It had lost its previous dye and did not appear to be attached to much.The remainder of the cuff (middle and left side) were intact but were oversewn for good measure.Estimated blood loss: scant.Drains: none.Specimens: none.Complications: none; patient tolerated the procedure.Additional information was requested, and the following was obtained: the sales rep reported that stratafix spiral suture sxpp1b406 may also been used on the patient.The rep reported that the dermabond was removed by the patient at 5 weeks.The rep says the doctor does not see patients until 5-6 weeks post-op and that is why the dermabond was not removed earlier.The surgeon always does 2 back stitches with stratafix.Post op instructions for all patients includes no intercourse for 8 weeks and examination prior to clearance.No estrogen prior to healing.Lot number is unknown.No additional information is available.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.What is meant by ¿leaving a hole behind.¿? did the barbs not hold in the tissue post op? did the stratafix suture break? if so, where was the break noted (termination, middle, end)? did the suture pull out of the tissue? were there any patient stress factors that led to the suture breaking or pulling out of the tissue? if not already given, please provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure.Date and name of index surgical procedure? patient 1: march 11, 2025 - robotic hysterectomy with bilateral salpingectomy, right oophorectomy, extensive excision of endometriosis, left ureterolysis patient 2: jan 2025 robotic hysterectomy patient 3: unknown date ¿ unknown procedure the diagnosis and indication for the index surgical procedure? what was the initial approach for the index surgical procedure? (open, laparoscopic or other)? on what tissue was the suture used? what was the tissue condition (normal, thin, calcified, fragile, diseased)? 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? please describe the appearance of the suture during the second procedure.Onset date/time of dehiscence? (# post op days) please describe any surgical intervention required for the wound dehiscence including date and findings.Did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement or during any re-operation? what symptoms did the patient experience following the index surgical procedure? onset date? other relevant patient history/concomitant medications? 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? dermabond advanced questions for active postal worker: is a photo available of patient reaction? description of event, symptoms, manifestation of reaction infection were oral steroids prescribed? if yes, provide specify.Were any cultures taken? results? please describe how the adhesive was applied.What prep was used prior to, during or after adhesive use? was a dressing placed over the incision? if so, what type of cover dressing used? is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? is the patient hypersensitive to pressure sensitive adhesives? was patient screening done prior the procedure, e.G.Check patient not allergic to cyanoacrylate, formaldehyde, bac, pressure-sensitive adhesive? patient pre-existing medical conditions (ie.Allergies, history of reactions) has the patient used or been exposed to similar glues/agents for repair, crafts, cosmetic use (lashes, nails)? was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure? lot number of dermabond? current patient status.What is the physician¿s opinion as to the etiology of or contributing factors to this event? when was the dermabond removed?.
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.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: additional information received from rep: possible lot numbers: sxpp1b450, lot#: 105a90 and sxpp1b406, lot#: 1013lk.Representative samples will be returned.Investigation summary: the product was returned to ethicon for evaluation.Fifteen unopened samples were received for analysis.Product code: sxpp1b406.Following the sampling plan, a visual inspection was conducted on thirteen samples, the packets were examined for visual defects: appearance, color package, wrinkles in the seal area, continuous seals, seal margins, over-sealing, damage (torn, punctured) and none was observed.The packets were opened, and the swage and attachment area were noted to be as expected.During the visual inspection, the sutures were correctly placed on the winding former.The sutures were dispensed without a problem and examined along of the strand and no anomalies or damaged on the suture surface could be observed.Additionally, the barbs were measured of the strands, and all barbs met the requirements.No conclusion could be reach on the cause of the reported event.As part of the ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.Additional information: d4, h4 - the actual device batch number associated with this event is not known.Two possible batch numbers are reported as follows: lot#: 1013lk; mfg.Date: 05/16/2024.Exp.Date: 04/30/2026.A manufacturing record evaluation was performed for the possible finished device lot, and no non-conformance's were identified.

• Brand Name: SFXSPI PDS+ UNI VIO 6IN 0 SA CT-1
• 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 PR 00754
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 22100650
• Report Number: 2210968-2025-05958
• Device Sequence Number: 7343284
• Product Code: NEW
• UDI-Device Identifier: 10705031236097
• UDI-Public: 10705031236097
• Combination Product (Y/N): Y
• Initial Reporter State: WA
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2025

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 Catalogue Number: SXPP1B406
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2025
• Supplement Date Received by Manufacturer: 05/30/2025
• Initial Report FDA Received Date: 05/28/2025
• Supplement Report FDA Received Date: 06/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Age: 46 YR
• Patient Sex: Female