MAUDE Adverse Event Report: ETHICON INC. SFXSYM PDS+ UNI VIO 24IN 1 SA CT; SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

Catalog Number	SXPP1A444
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a cabg with avr procedure on (b)(6) 2025 and suture was used.During the procedure the barbed sutures broke during suturing.It was reported that a needle broke.There were no patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4) date sent to the fda: 10/15/2025.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, and no non-conformances were identified.Additional information was requested; the following was obtained: what was the name of the procedure? please clarify, how many stratafix sutures break during suturing? please confirm the knot was found on prolene suture (w8556).Was there any change in the patient¿s post-operative care due to the prolonged procedure? please perform and document the follow up attempt for product return.Please document the shipment tracking number in notes or rmao sections.Please provide the source or name and title of external person providing answers to follow-up (external person submitting answers to sales rep or loc/bq) 1.Stratafix breakage name of procedure cabg and atrial valve replacement, during both of these surgeries stratafix broke while closing the fascia layer.Prolene¿s needle broke during atrial valve replacement surgery.2.Three stratafix broke during the surgery which needs to be replaced and since all are from same lot, lot needs to be replaced.3.Knot was found on strtafix suture 4.Breakage of prolene's needle while suturing was reported to be high risk incident by doctor.5.This incident was reported by dr.(b)(6) who was the surgeon of following cases.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.The following information was reported: knot was present in the suture was surgery delayed due to the reported event? yes, if yes, number of minutes: 6, was procedure successfully completed? yes, were fragments generated? yes, if yes, were they removed easily without additional intervention? unknown, patient status/ outcome / consequences no, was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: unknown, is the patient part of a clinical study unknown, additional information was requested; the following was obtained: please confirm that the cabg and atrial valve replacement was completed during one patient procedure.Please advise, was there any patient consequence due to the prolene needle breakage? during multiple surgeries of cabg fascia closure, the sxpp1a444 suture broke while trying to attain a tension and one of the sutures had a small knot in the beginning.All problems were raised from same lot during multiple surgeries -product lot-1036pl and is requested for replacement.The w88556 suture¿s needle tip broke during a different avr case on the same day.Cabg and avr are two different patient procedures which occurred on the same day by the same surgeon.No, patient consequences was reported due to prolene needle breakage.Cabg and avr are two different patient procedures which occurred on the same day by the same surgeon.No, patient consequences was reported due to prolene needle breakage.

• Brand Name: SFXSYM PDS+ UNI VIO 24IN 1 SA CT
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; calle durango #2751; ciudad juarez 32575 ; MX 32575
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 23310208
• Report Number: 2210968-2025-11928
• Device Sequence Number: 5826794
• Product Code: NEW
• UDI-Device Identifier: 10705031245235
• UDI-Public: (01)10705031245235(17)260831(10)1036PL
• Combination Product (Y/N): Y
• Initial Reporter Country: IN
• PMA/510(K) Number: K141776
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/16/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2026
• Device Catalogue Number: SXPP1A444
• Device Lot Number: 1036PL
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2025
• Initial Report FDA Received Date: 10/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/03/2024
• 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
• Patient Sex: Unknown