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); Swelling/ Edema (4577)

Event Date 10/26/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint # (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.The manufacturing records could not be reviewed as the batch number is unknown.(b)(4).Summary: five used sutures pieces were received to ethicon inc for evaluation, the product code should be sxpp1a445.During the visual inspection of the product received, the sutures pieces appear to be pds stratafix and tissue, body fluids and several damaged caused by degradation process were observed.Two important characteristics describe the in vivo performance of absorbable devices: first, tensile strength retention, and second, the absorption rate (loss of mass).Stratafix¿ symmetric pds¿ plus device has been formulated to minimize the variability of these characteristics and to provide wound support through an extended healing period.Stratafix¿ symmetric pds¿ plus device is completely absorbed by 210 days post implantation.The results of implantation studies indicate the percentage of original strength that is retained (14 days 75%, 28 days 65%, 42 days 55%).Stratafix¿ symmetric pds¿ plus device, being absorbable, is not to be used where prolonged (beyond six weeks) approximation of tissue under stress is required and is not to be used in conjunction with prosthetic devices (i.E., heart valves or synthetic grafts).The product is absorbable suture, as the sample was received open, the time of exposure to the environment could not be determined and a functional test cannot be performed.Attempts are being made to clarify 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 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 caused the swelling diagnosed on (b)(6) 2021? was the drained fluid from the office visit on (b)(6) 2021 cultured? if yes, results? was there any issue with the suture that was used on the right knee from the initial procedure on (b)(6) 2021? if yes, please specify did the patient undergo any re-operation for the right knee? if yes, please provide specifics and date.After the re-operation for the left knee on (b)(6) 2021, while in the hospital, it was stated¿ the patient¿s right knee then gave way, almost falling¿ and ¿on exam of the r knee, she has a palpable defect over the superior medial patellar border¿ please provide additional details of what was found on this exam.Was there any issue found with the suture on the right knee at this time? was any intervention required for the right knee? what is the physician¿s opinion as to the etiology of or contributing factors to these events? what is the patient's current status? trade name - irgacare®.Active ingredient(s) ¿ triclosan.Dosage form ¿ suture/solid/parenteral.Strength = 2360 g/m.Events were submitted via 2210968-2021-12183 ( left knee) and 2210968-2021-12184 ( right knee).

Event Description

It was reported that the patient underwent a bilateral total knee arthroplasty on (b)(6) 2021 and the 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 visited a doctor due to increased swelling and pain/tightness with full extension.35cc fluid was aspirated.On (b)(6) 2021, there was another office visit due to post-op fall; the patient landed on both knees.Now the patient is experiencing significant knee pain, left knee more than right, and inability to extend her left knee.Exam reveals an obvious deformity of the overlying skin at the superior medial patellar border, palpable defect, 2+ effusion and ability to manually sublux patella laterally.On (b)(6) 2021, the patient underwent an open repair of left knee medial retinaculum.It was also stated that post op, the suture was frayed and was popping above the knee/patella.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: 12891544
• MDR Text Key: 281393924
• Report Number: 2210968-2021-12183
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2021
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2021
• Date Manufacturer Received: 11/04/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Weight: 94 KG