MAUDE Adverse Event Report: ETHICON INC. SFX SPI MCRYL+ UNI 24IN 3-0 SA PS-2 PRM; SUTURE, SURGICAL, ABSORBABLE, POLYGLCOLIC ACID

Catalog Number	SXMP1B108
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Wound Dehiscence (1154)
Date of Event	06/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional information: h6 component code: g07002 - device not returned.Additional information: doctor use sxpp1a203 for joint capsule, vicryl for subcutaneous fat, sxmp1b108 for subcuticular and clr222us for skin.Did the patient experience an adverse event such as infection, non-union, allergic reaction, osteoporosis, overloading, pain, degenerative diseases, bleeding or oozing? unknown, did the patient require revision surgery or hardware removal? unknown, patient status/ outcome / consequences yes, patient consequence description/was there a clinical outcome experienced by the patient (infection, inflammation, etc.)? wound dehiscence, 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 has been requested however not received.If further details are received at a later date a supplemental medwatch will be sent.Was the dehiscence only in the sxmp1b108 for subcuticular or with other layers too ? on what tissue was the suture used/location of suture placement? what tissue dehisced? what was the tissue condition (normal, thin, calcified, fragile, diseased)? how was the suture placed (interrupted or continuous)? how was the suture tied (square knot or multiple knots one end)? onset date/time of dehiscence? (# post op days) 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.Were there any precipitating stress factors for the sutures untying, breakage or pulling out of the tissue? did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement and during any re-operation? note: events reported on: mw# 2210968-2023-05910 , mw# 2210968-2023-05911, mw# 2210968-2023-05912.No product available for return.This is a combination product, and the event has been reviewed for both the suture and the triclosan.Trade name - irgacare® active ingredient(s) ¿ triclosan dosage form ¿ suture/solid/parenteral strength ¿ = 2360 g/m.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.
Event or Problem Description
It was reported a patient underwent a total knee arthroplasty on an unknown date and barbed suture was used.Found wound dehiscence in subcuticular layer after 1 month when patient came to physical therapy.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.
Additional Manufacturer Narrative
Product complaint #(b)(4).Additional information provided: physician removed prineo 7 days after operation the wound was closed completedly, 4-5 days after that patient came to hospital for follow up and physical therapy.During the physical therapy there is a wound dehiscence in subcutaneous at distal, no suture find when look into the wound.Fascia use sxpp1a203 by continuous suture, and use vicryl by interrupted suture.Subcuticular use sxmp1b108 by continuous suture.Subcutaneous fat use vicryl by inyerrupted suture.Skin use prineo.Patient is female, about 160 cm height, and weight 70 kg.Note: events reported on: mw# 2210968-2023-05910, mw# 2210968-2023-05911, mw# 2210968-2023-05912, and mw# 2210968-2023-07075.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.

• Brand Name: SFX SPI MCRYL+ UNI 24IN 3-0 SA PS-2 PRM
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE, POLYGLCOLIC 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 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 17553218
• Report Number: 2210968-2023-05910
• Device Sequence Number: 11991264
• Product Code: GAM
• UDI-Device Identifier: 10705031236646
• UDI-Public: 10705031236646
• Combination Product (Y/N): Y
• Initial Reporter Country: TH
• PMA/510(K) Number: N12159
• 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,Followup,Followup,Followup
• Report Date (Section B): 10/12/2023

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: SXMP1B108
• 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: Not provided
• Supplement Date Received by Manufacturer: 08/29/2023; 08/29/2023; 09/28/2023
• Initial Report FDA Received Date: 08/15/2023
• Supplement Report FDA Received Date: 09/21/2023; 09/27/2023; 10/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Female
• Patient Weight: 70 KG