MAUDE Adverse Event Report: ETHICON INC. SFXSPI PDS+ UNI VIO 9IN 0 SA CT-1; SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

Catalog Number	SXPP1B455
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Hematoma (1884); Seroma (2069)
Date of Event	01/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent a robotic hernia procedure on an unknown date and a barbed suture was used.Post-op, the patient experienced a seroma or hematoma.The suture material was not holding tissue compressed adequately.The patient required an emergency department visit.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.D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.H6 component code: g07002 device not returned 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.Case 1- (b)(4).¿ required ed visit.Case 2- (b)(4).¿ required ed visit.Case 3- (b)(4).¿ no ed visit required, handled in office.Were all 3 cases robotic hernia procedures? did all 3 patients have a seroma? did all 3 patients have a hematoma? did all 3 patients experience the suture material not holding tissue adequately? please provide the following information for each patient: 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? 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? what is meant by ¿suture material is not holding tissue compressed adequately¿ did the wound dehis? if yes, what tissue dehisced? onset date/time of dehiscence? (# post op days) is it known how the wound dehisced? did the sutures barbs not engage in the tissue? did the suture pull out of the tissue? did the suture break? if so, where was the break noted (termination, middle, end)? 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, if applicable.Did the stratafix suture break? if so, where was the break noted (termination, middle, end)? were there any precipitating stress factors for the suture breakage or pulling out of the tissue? when did the hematoma occur? what was the source and triggering event of hematoma? what was the volume of blood loss? how was the hematoma treated? please describe any medical/surgical intervention required for the seroma and/or hematoma, including results.Did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement and 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? lot number?.

• Brand Name: SFXSPI PDS+ UNI VIO 9IN 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 ; * 00754
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 22012033
• Report Number: 2210968-2025-05278
• Device Sequence Number: 5228742
• Product Code: NEW
• UDI-Device Identifier: 10705031240834
• UDI-Public: 10705031240834
• 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
• Report Date (Section B): 05/13/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: SXPP1B455
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2025
• Initial Report FDA Received Date: 05/13/2025
• 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
• Patient Sex: Unknown