MAUDE Adverse Event Report: ETHICON INC. SFXSPI MCL+ BI UD 12IN2 3-0 DA PS PR; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Catalog Number	SXMP2B412
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Codes	Necrosis (1971); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent an unknown procedure in 2025 and barbed suture was used.The suture is not dissolving or breaking down in the time frame that it should.The patient would have to come back.No adverse impact on patient/user was reported.Device is not available for return.Additional information has been 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.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.- was there any medical or surgical intervention performed (product removed; re-operation; re-suturing; re-closure; drainage)? if so, please specify.- was a prescription for steroids or antibiotics issued for the patient's recovery? if yes, please provide medication name, route and dose.- how many devices demonstrated the alleged deficiency? please specify by product code and lot number: product code sxmp2b412 - lot unknown: product code sxmp1b421 - lot unknown: product code sxmp1b102 - lot unknown: - please provide the lot number of products sxmp2b412, sxmp1b421 and sxmp1b102.- provide the source or name and title of external person providing answers to follow-up (external person submitting answers to sales rep).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 it has been reported that the device will not be returned.If the device or further details are received at a later date a supplemental medwatch will be sent.H6 component code: g07002 ¿ device not returned.
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: b1, b2, c1, g1.Corrected information: h1, h6.Additional information was requested, and the following was obtained: - have any of these events been previously reported to ethicon? if so, provide the respective reference number(s).If no, please create a new pc file for each patient/event.It was reported that "¿encountered 7 instances where the patient would have to come back."it was notated by the or manager that there were 7 patients, but not all at this facility and she was not aware of specific patient identifiers for each instance - was there any medical or surgical intervention performed (product removed; re-operation; re-suturing; re-closure; drainage)? if so, please specify.Yes, patients had to be brought back and necrotic tissue had to be removed - was a prescription for steroids or antibiotics issued for the patient's recovery? if yes, please provide medication name, route and dose.Unknown - how many devices demonstrated the alleged deficiency? please specify by product code and lot number: product code sxmp2b412 - lot unknown: product code sxmp1b421 - lot unknown: product code sxmp1b102 - lot unknown: - please provide the lot number of products sxmp2b412, sxmp1b421 and sxmp1b102.Unknown.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 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 each stratafix suture used? what was the tissue condition (normal, thin, calcified, fragile, diseased)? for the stratafix spiral monocryl plus unidirectional: 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? for the stratafix spiral monocryl plus bi-directional: were two loose passes with each arm of the device performed at the initiation of suture use during the index procedure? was at least one pass in reverse direction performed prior to closure? how many days post-op did the necrosis occur? does the surgeon believe the suture not dissolving contributed to the tissue necrosis? please describe any medical/surgical intervention required for this suture event including dates and results.Can you describe the appearance of the stratafix suture during second procedure.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? 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.Additional information: e1, e3.Additional information was requested, and the following was obtained: the reporting surgeon is dr.(b)(6).When i initially spoke to him about the incident, he did attribute the tissue necrosis to the ¿slow absorption of the suture¿ all the pc numbers are in line with the same reported issue.The reason i did not initially file 7 separate reports is because not all 7 patients were initially operated on at the same facility.I did request a breakdown on each patient operation date and facility but was told that he didn¿t have the information available.The hospital did raise concerns about this incident attributing to the pa¿s technique.I have been working with the hospital to target this pa for a professional education course.I have made several attempts to get these responses from the surgeon and facility and have not heard back.I did request a response for the questions you provided and have not heard back from dr.(b)(6).

• Brand Name: SFXSPI MCL+ BI UD 12IN2 3-0 DA PS PR
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
• 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: 22968466
• Report Number: 2210968-2025-10157
• Device Sequence Number: 9062138
• Product Code: GAM
• UDI-Device Identifier: 10705031464285
• UDI-Public: 10705031464285
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K192580
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/15/2025

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: SXMP2B412
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2025
• Supplement Date Received by Manufacturer: 09/15/2025; 10/13/2025
• Initial Report FDA Received Date: 09/04/2025
• Supplement Report FDA Received Date: 09/26/2025; 10/15/2025
• 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