MAUDE Adverse Event Report: ETHICON INC. SFXSPI PDS+ UNI VIO 27IN 0 SA CT-1; SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

Catalog Number	SXPP1B408
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Hemorrhage/Blood Loss/Bleeding (1888); Insufficient Information (4580)
Date of Event	02/08/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was that a patient underwent a c-section on (b)(6) 2026 and barbed suture was used.The patient was readmitted to the hospital as there was an entire section of suture missing from the wound closure as if it had been completely absorbed.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.A manufacturing record evaluation was performed for the finished device lot number, and no related non-conformances were identified.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: did the patient have a wound dehiscence? how many stratafix spiral pds plus sutures were used during this procedure? please confirm the quantity of sutures that were completely resorbed post operatively for this patient.What is the surgeon¿s experience with this stratafix suture? the timing that the suture was completely absorbed.Please provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure.Were any concomitant procedures performed? on what tissue was the suture used? what was the tissue condition (normal, thin, calcified, fragile, diseased)? for the original intended closure, how were all layers closed? what symptoms did the patient experience following the index surgical procedure? onset date? 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 tissue dehisced? onset date/time of dehiscence? (# post op days) how was the dehiscence managed? please describe any surgical intervention required for the wound dehiscence including date and findings.Please describe the appearance of the suture during the second procedure.Did the suture break? if so, where was the break noted (termination, middle, end)? were there any precipitating patient stress factors that led to the sutures breaking or pulling out of the tissue? are photos available? did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement or during any re-operation? 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? will product be returned? if so, please provide the return date and tracking information.Investigation summary: the product was returned to ethicon for evaluation.One open box with (b)(4) representative unopened samples was received for analysis.Product code sxpp1b408.The complaint sample was not received for evaluation.Upon initial inspection of the samples, no external damages were observed on the external packets.In order to evaluate the condition of the returned samples, the packets were opened, and the swage and attachment area were noted to be as expected.The sutures were dispensed without problems and examined along the strand to detect any issue related to the customer complaint and no defects were observed during evaluation.The functional test was performed using instron equipment and the tensile force was above the minimum requirements.The event described could not be confirmed as the device performed without any defect noted.As part of the ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.The event described could not be confirmed as no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.
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: a3a, a4, b2 required intervention, h6 health effect - clinical code, h6 health effect - impact code.Additional information was requested, and the following was obtained: did the patient have a wound dehiscence? - yes, partial.How many stratafix spiral pds plus sutures were used during this procedure? 2.Please confirm the quantity of sutures that were completely resorbed post operatively for this patient.Part of 1.What is the surgeon¿s experience with this stratafix suture? uses it for every c/s.The timing that the suture was completely absorbed.Unsure.Please provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure.Were any concomitant procedures performed? no.On what tissue was the suture used? fascia.What was the tissue condition (normal, thin, calcified, fragile, diseased)? normal.For the original intended closure, how were all layers closed? yes.What symptoms did the patient experience following the index surgical procedure? onset date? pulling, bleeding, (b)(6) 2026.Was the fixation loop secured to tissue at the initiation of suture use during the index procedure? unsure, i was not in procedure.Was at least one reverse stitch performed prior to closure? unsure.What tissue dehisced? from skin to fascia.Onset date/time of dehiscence? (# post op days) 2.How was the dehiscence managed? returned to hospital, exploratory lap and repair with 0 pds.Please describe any surgical intervention required for the wound dehiscence including date and findings.Please describe the appearance of the suture during the second procedure.Unsure, was not in surgery.Did the suture break? if so, where was the break noted (termination, middle, end)? were there any precipitating patient stress factors that led to the sutures breaking or pulling out of the tissue? are photos available? did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement or during any re-operation? 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? will product be returned? if so, please provide the return date and tracking information.

• Brand Name: SFXSPI PDS+ UNI VIO 27IN 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: 24560941
• Report Number: 2210968-2026-02468
• Device Sequence Number: 9330817
• Product Code: NEW
• UDI-Device Identifier: 10705031236110
• UDI-Public: (01)10705031236110(17)270930(10)10BEXA
• Combination Product (Y/N): Y
• Initial Reporter State: TN
• 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): 03/25/2026

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: SXPP1B408
• Device Lot Number: 10BEXA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2026
• Supplement Date Received by Manufacturer: 03/17/2026
• Initial Report FDA Received Date: 03/10/2026
• Supplement Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/09/2025
• 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; Other
• Patient Sex: Female
• Patient Weight: 69 KG