MAUDE Adverse Event Report: ETHICON INC. SFXSPI MCL+ UNI UD 12IN 3-0 SA PS-1 PMP; SUTURE, SURGICAL, ABSORBABLE, POLYGLCOLIC ACID

Catalog Number	SXMP1B101
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Unspecified Infection (1930)
Date of Event	07/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint #: (b)(4).Additional information: h6 component code: g07002 - device not returned, d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.Additional information provided: the deeper layer was still in tact with a 2/0 suture being used for that layer.Barbed suture and topical skin adhesive was used.The patient was instructed to keep the adhesive on for two weeks as per normal practice.Dr performed the procedure and closure as he usually would.Has been using stratafix and prineo for several months, application of products has been observed.Patient status/outcome/consequences: yes.Patient consequence description/was there a clinical outcome experienced by the patient (infection, inflammation, etc.)? infection, dishiscence and readmission for new implant to be implanted.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 and received.If further details are received at a later date a supplemental medwatch will be sent.What was the implanted device? pacemaker.2.Why did a new device need to be implanted? a new device was implanted due to the infection.3.What was the site of implantation? below the collar bone.4.Is the implant related to the reported event? no.Prineo and stratafix were used and an infection occurred so the case was reported.5.How was it addressed? new implant put in after infection was cleared.Prineo not used on second admission.6.What was the date of the event? new implant put in (b)(6), original case a month prior.Additional information has been requested however not received.If further details are received at a later date a supplemental medwatch will be sent.Is photo available of patient infection ? what was the procedure date? what date/day post op was the infection noted? was any prescription strength medication prescribed? please specify? were any cultures taken? results? please describe how the adhesive was applied.What prep was used prior to, during or after adhesive use? was a dressing placed over the incision? if so, what type of cover dressing used? is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? is the patient hypersensitive to pressure sensitive adhesives? was patient screening done prior the procedure, e.G.Check patient not allergic to cyanoacrylate, formaldehyde, bac, pressure-sensitive adhesive? patient demographics: initials/id, gender, age or date of birth; bmi.Patient pre-existing medical conditions (ie.Allergies, history of reactions).Has the patient used or been exposed to similar glues/agents for repair, crafts, cosmetic use (lashes, nails)? was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure? product code and/or lot of product used? current patient status.Name of surgeon? what is the physician¿s opinion as to the etiology of or contributing factors to this event? is product available to return for analysis.Suture dehiscence: 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)? 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? did the stratafix suture break? if so, where was the break noted (termination, middle, 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? suture infection: description of event, symptoms, manifestation of infection.Did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement or during any re-operation? product lot of product used? if applicable, will product be returned? if so, please provide the return date and tracking information.Please describe the patient manifestations of the reported infection (location, severity, appearance, systemic or local infection).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 any pre-op cleansing procedures changed recently? if yes, please describe were cultures 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.No product is 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 pacemaker procedure on an unknown date in 2024 and barbed suture was used.Surgeon implanted a device and three weeks later the patient had to be readmitted due to superficial dehiscence and infection.New implant put in after infection was cleared.New implant put in (b)(6), original case a month prior.Additional information has been requested.

• Brand Name: SFXSPI MCL+ UNI UD 12IN 3-0 SA PS-1 PMP
• 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 ; * 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 19983282
• Report Number: 2210968-2024-08507
• Device Sequence Number: 15474494
• Product Code: GAM
• UDI-Device Identifier: 10705031236776
• UDI-Public: 10705031236776
• Combination Product (Y/N): Y
• Initial Reporter Country: AS
• 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
• Report Date (Section B): 08/14/2024

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: SXMP1B101
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2024
• Initial Report FDA Received Date: 08/14/2024
• 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