MAUDE Adverse Event Report: ETHICON INC. STFX SYM PDS+ UNI VIO 24IN 1 S/A CTX; SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

Model Number SXPP1A445

Device Problems Break (1069); Material Frayed (1262)

Patient Problems Pain (1994); Loss of Range of Motion (2032)

Event Date 10/02/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).This is a combination product, and the event has been reviewed for both the suture and the triclosan.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Trade name - irgacare®, active ingredient(s) ¿ triclosan, dosage form ¿ suture/solid/parenteral, strength ¿ = 2360 ug/m all others.(b)(4).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 gender and bmi at the time of index procedure on what tissue was the suture used? what was the tissue condition (normal, thin, calcified, fragile, diseased)? did surgeon change any pre-op, intra-op or post -op surgery regimen? were there any pre-existing signs/symptoms of active inflammation/infection prior to this surgical procedure? other relevant patient history/concomitant medications? what is the lot number? was the fixation tab seated against the tissue at the initiation of suture use during the index procedure? how was the incision done, please specify.Was it curvilinear or straight? were two reverse stitches performed across the incision prior to closure? did the operating surgeon observe any suture deficiency or anomaly before or during suture placement? what instruments were used in this procedure to handle the suture? was there a precipitating stress factor for the post-op suture breaking/fraying? was there a wound dehiscence? was the tissue torn around the suture closure? what is the physician¿s opinion as to the etiology of or contributing factors to these events? what is the patient's current status?.

Event Description

It was reported that the patient underwent a right total knee arthroplasty on : (b)(6) 2021 and barbed suture was used.The suture was placed bottom to top and backed stitched twice as per ifu.It was confirmed no extra tension was placed.There were no needle drivers used for handling suture.The knee was closed at flexion from 70-90 degrees.On (b)(6) 2021, the patient had an office visit with complaints of r knee pain, loss of 25 degrees rom/strength, palpable defect along the superior medial patellar border.On (b)(6) 2021, the patient underwent an open repair r knee medial retinaculum.It was clarified that the suture not only broke in the middle, but that the suture delaminated/frayed in 1 point at the middle of the closure line.The sales rep stated the middle of the suture looked frayed/unraveled.It split longitudinally.Additional information has been requested.

• Brand Name: STFX SYM PDS+ UNI VIO 24IN 1 S/A CTX
• Type of Device: SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; avenida de las torres 7125; col salvacar; ciudad juarez 32604 ; MX 32604
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 12920804
• MDR Text Key: 281733060
• Report Number: 2210968-2021-12304
• Device Sequence Number: 1
• Product Code: NEW
• UDI-Device Identifier: 10705031245273
• UDI-Public: 10705031245273
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K141776
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/02/2021

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
• Device Operator: Health Professional
• Device Model Number: SXPP1A445
• Device Catalogue Number: SXPP1A445
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/09/2021
• Initial Date FDA Received: 12/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR
• Patient Weight: 59 KG