MAUDE Adverse Event Report: ETHICON INC. SFXSPI PDS+ UNI VIO 12IN 3-0 SA PS-2 PR; SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

Catalog Number	SXPP1B104
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Post Operative Wound Infection (2446)
Type of Reportable Event	Serious Injury
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.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.What is the surgeon¿s experience with this stratafix suture? 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? were any concomitant procedures performed? 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)? for the original intended closure, how were all layers closed? 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 the patient manifestations of the reported infection (location, severity, appearance).Please provide the onset date/time of infection from the initial surgical procedure.Were there any pre-existing signs/symptoms of active infection prior to this surgical procedure? did the patient receive any prophylactic antibiotics pre-, intra- or post-operation? were cultures and sensitivities performed? if so, please provide the results.How much and what type of drainage is present in this wound? please describe any medical intervention performed including medication name and results.Were any pre-op cleansing procedures changed recently? if yes, please describe 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? lot number? surgeon¿s name? please clarify: the event stated it ¿was not a control release needle¿.Why was this stated in the event? did the suture pull off the suture?.
Event or Problem Description
It was reported a patient underwent an unknown procedure on an unknown date and a barbed suture was used.Post-op, an infection occurred.No sample will be returned.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.Additional information: health effect - impact code.Additional information was requested, and the following was obtained: in a case a patient who had a plate inserted under the ankle in december had an infection approximately six weeks after surgery.The infection was contained within the subcutaneous tissue.Spiral sutures were used for dermal closure.The plate was removed and the area sutured with nylon.The patient has not yet fully recovered but is gradually recovering.The doctor said that infection occurred only in cases where the implant was placed in the foot.No infections occurred in cases such as the calf or thigh, so it may have not been a good idea to use the implant in areas with thin subcutaneous tissue.Additional information was requested, and the following was obtained: what is the surgeon¿s experience with this stratafix suture? stratafix spiral was used for dermal closure in a foot/ankle case involving a plate; an infection occurred approximately 6 weeks post op.The surgeon notes infections have only occurred in foot implant cases and suspects use over thin subcutaneous tissue may be a contributing factor.Overall duration/volume of prior experience is not provided no further information is available.Please provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure.No further information is available.Date and name of index surgical procedure? (b)(6) (exact date unk); plate implantation below the malleolus (foot/ankle).The diagnosis and indication for the index surgical procedure? specific diagnosis/indication unk (plate fixation suggests an orthopedic indication near the ankle).Were any concomitant procedures performed? no further information is available.What was the initial approach for the index surgical procedure? (open, laparoscopic or other)? open (orthopedic plate implantation).On what tissue was the suture used? dermis (stratafix spiral used for dermal closure).What was the tissue condition (normal, thin, calcified, fragile, diseased)? the surgeon suspects thin subcutaneous/soft tissue at the ankle; exact dermal condition otherwise unk.For the original intended closure, how were all layers closed? dermis closed with stratafix spiral; other layer closure details unk.Was the fixation loop secured to tissue at the initiation of suture use during the index procedure? no further information is available.Was at least one reverse stitch performed prior to closure? no further information is available.Please describe the patient manifestations of the reported infection (location, severity, appearance).Location: below the malleolus (ankle region).Depth: limited to subcutaneous tissue.Severity/appearance specifics not described; no systemic signs reported.Please provide the onset date/time of infection from the initial surgical procedure.Approximately 6 weeks after the index procedure.Were there any pre-existing signs/symptoms of active infection prior to this surgical procedure? no further information is available.Did the patient receive any prophylactic antibiotics pre-, intra- or post-operation? no further information is available.Were cultures and sensitivities performed? if so, please provide the results.No further information is available.How much and what type of drainage is present in this wound? no further information is available.Please describe any medical intervention performed including medication name and results.Hardware (plate) removal and re closure with nylon; medication details unk.Post intervention status: improving but not fully healed.Were any pre-op cleansing procedures changed recently? if yes, please describe no further information is available.Did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement or during any re-operation? no suture/needle anomaly has been reported; unk if specifically assessed.Other relevant patient history/concomitant medications? no further information is available.What is the physician¿s opinion as to the etiology of or contributing factors to this event? infections have only occurred in foot cases with implants; the surgeon believes use over areas with thin subcutaneous tissue (ankle/foot) may have contributed.What is the patient's current status? not fully healed but gradually improving.Lot number? unk.No further information is available.Surgeon¿s name? unk.No further information is available.Please clarify: the event stated it ¿was not a control release needle¿.Reason for this statement is unk in the provided information; no control release detachment issue has been reported.Why was this stated in the event? no further information is available.Did the suture pull off the suture? no such event has been reported; based on available information, unk/no evidence.

• Brand Name: SFXSPI PDS+ UNI VIO 12IN 3-0 SA PS-2 PR
• 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: 24470367
• Report Number: 2210968-2026-02098
• Device Sequence Number: 13293426
• Product Code: NEW
• UDI-Device Identifier: 10705031236240
• UDI-Public: 10705031236240
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K182873
• 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): 03/13/2026

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: SXPP1B104
• 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: 02/18/2026
• Supplement Date Received by Manufacturer: 03/03/2026
• Initial Report FDA Received Date: 02/27/2026
• Supplement Report FDA Received Date: 03/13/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown