MAUDE Adverse Event Report: ETHICON INC. SFXSPI PDS+ UNI VIO 27IN 2-0 SA CT-1; SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

Catalog Number	SXPP1B412
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Wound Dehiscence (1154)
Date of Event	01/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent a panniculectomy on an unknown date and barbed suture was used.The patient had a ¿breakdown¿ of their incision and surgeon had to reoperate.Surgeon said he doesn¿t believe it to be anything to do with the closing sutures but not sure what happened.Patient's husband said that he sprayed an ¿antibacterial¿ substance on patient's incision post op.Surgeon said it could have had something to do with it.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.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? 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? what tissue dehisced? please describe the appearance of the suture during the second procedure.Did the stratafix suture break? if so, where was the break noted (termination, middle, end)? did the sutures barbs not engage in the tissue? 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? 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? surgeon¿s name?.
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.Corrected information: h6 health effect - impact code.Additional information: a2, e1.Additional information was requested, and the following was obtained: date of index surgical procedure? unknown.On what tissue was the suture used? subcutaneous fat layer.What was the tissue condition (normal, thin, calcified, fragile, diseased)? unknown.Was the fixation loop secured to tissue at the initiation of suture use during the index procedure? yes.Was at least one reverse stitch performed prior to closure? yes.What tissue dehisced? according to surgeon, yes it was dehisced.Please describe the appearance of the suture during the second procedure.Unknown did the stratafix suture break? if so, where was the break noted (termination, middle, end)? unknown if it broke or separated from tissue did the sutures barbs not engage in the tissue? unknown.Did the suture pull out of the tissue? uknown.Were there any patient stress factors that led to the suture breaking or pulling out of the tissue? unknown, but patient said an "antibacterial" spray was applied to it post op by patient.Onset date/time of dehiscence? (# post op days) uknown.Please describe any surgical intervention required for the wound dehiscence including date and findings.Surgeon reapproximated the incision.Did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement or during any re-operation? unknown.What symptoms did the patient experience following the index surgical procedure? onset date? unknown.Other relevant patient history/concomitant medications? unkown.What is the physician¿s opinion as to the etiology of or contributing factors to this event? unknown.What is the patient's current status? unknown.Lot number? unknown.Surgeon's name? (b)(6) dr.

• Brand Name: SFXSPI PDS+ UNI VIO 27IN 2-0 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: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 21565172
• Report Number: 2210968-2025-02531
• Device Sequence Number: 4373708
• Product Code: NEW
• UDI-Device Identifier: 10705031236158
• UDI-Public: 10705031236158
• Combination Product (Y/N): Y
• Initial Reporter State: AZ
• 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): 03/14/2025

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: SXPP1B412
• 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: 02/26/2025
• Supplement Date Received by Manufacturer: 03/11/2025
• Initial Report FDA Received Date: 03/10/2025
• Supplement Report FDA Received Date: 03/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Unknown