MAUDE Adverse Event Report: ETHICON INC. SFXSPI PDS+ UNI VIO 6IN 3-0 SA SH; SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

Catalog Number	SXPP1B420
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #(b)(4) 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.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 the diagnosis and indication for the 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? please describe any medical/surgical intervention required for this suture event including dates and results.Did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement or during any re-operation? can you describe the appearance of the stratafix suture during the second procedure? did the suture break? if so, where was the break noted (termination, middle, end)? 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?.
Event or Problem Description
It was reported that a patient underwent a laparoscopy and endoscopy cooperative surgery on (b)(6) 2025 and a barbed suture was used on the lesser curvature of stomach.After gastric resection, continuous suturing was performed from the cardiac side using the barbed suture.As the suturing part was long and the suture was not enough, a second continuous suturing was performed from the pyloric side.When a drain was inserted, loosening of the suture was confirmed, so additional suturing was performed using another barbed suture.A leak test was done and there were no issues found, and the wound was closed.There were no adverse patient consequences, additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).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: a2, a3a.Additional information was requested, and the following was obtained: please provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure: age: 69 years; gender: male; weight: unk; bmi: unk.The diagnosis and indication for the index surgical procedure? lecs was performed following gastric (stomach) lesion resection.On what tissue was the suture used? gastric tissue at the resection/closure site.What was the tissue condition (normal, thin, calcified, fragile, diseased)? unk (no abnormal tissue condition was reported).Was the fixation loop secured to tissue at the initiation of suture use during the index procedure? unk.Was at least one reverse stitch performed prior to closure? unk.Please describe any medical/surgical intervention required for this suture event including dates and results.On (b)(6) 2025, additional suturing with spiral was performed intraoperatively after looseness was observed, and no leak was confirmed at that time; however, postoperative leakage was later identified, and on (b)(6) 2025 an open surgery was performed for abdominal lavage and additional suturing; the patient is currently recovering.Did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement or during any re-operation? the surgeon observed that the spiral suture appeared loose during drain placement; no breakage was reported.Can you describe the appearance of the suture during the second procedure? the suture was noted to be loose; no visible breakage was reported.Did the suture break? if so, where was the break noted (termination, middle, end)? no, the suture did not break.Did the suture barbs not engage in the tissue? unk.Did the suture pull out of the tissue? unk (loosening was observed, but pull-out was not clearly confirmed).Other relevant patient history/concomitant medications? no relevant past medical history, including diabetes; concomitant medications are unk.What is the physician¿s opinion as to the etiology of or contributing factors to this event? the physician believes that incorrect use of the spiral suture may have led to loosening, which contributed to the postoperative leak.What is the patient's current status? the patient has been hospitalized.Although the patient is recovering, oral intake has not yet been resumed.Lot number? unk.

• Brand Name: SFXSPI PDS+ UNI VIO 6IN 3-0 SA SH
• 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: 24034963
• Report Number: 2210968-2026-00234
• Device Sequence Number: 9074893
• Product Code: NEW
• UDI-Device Identifier: 10705031235809
• UDI-Public: 10705031235809
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2026

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 Catalogue Number: SXPP1B420
• 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: 12/19/2025
• Supplement Date Received by Manufacturer: 02/09/2026
• Initial Report FDA Received Date: 01/12/2026
• Supplement Report FDA Received Date: 02/20/2026
• 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
• Patient Age: 69 YR
• Patient Sex: Male