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

Model Number SXPP1A445

Device Problem Break (1069)

Patient Problems Wound Dehiscence (1154); Erythema (1840); Swelling (2091); Not Applicable (3189)

Event Date 08/26/2020

Event Type  Injury  

Manufacturer Narrative

(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.Additional information was requested, and the following was obtained: could you please confirm if the suture present fraying issues or breakage post op? suture had broken.Could you please confirm what do you mean by "suture spli"? suture line had broken.It reports 2 product involved, could you please confirm what was the issue for each one? both the sutures had broken or snapped.What was tissue condition? skin and external tissue was fine.Deeper tissue needed further repair.Was any surgical intervention or re-suturing performed? patient returned for a quad tendon repair and resuturing.Could you please provide lot number? box have been discarded.What is the event day and procedure date? original surgery was (b)(6).Second surgery was (b)(6).Should also note that patient was a heavy set (b)(6) lb patient.Patient had had a stumble on the stairs post op.Events submitted via 2210968-2020-07184.

Event Description

It was reported that the patient underwent a total knee arthroplasty on (b)(6) 2020 and the barbed suture was used in capsule layer.After closure procedure, quadricep tear post op occurred.The patient had had a stumble on the stairs post op and went back to or to discover patellar disruption and quad tendon tear.Swabs were negative.There was no infection, incision healed well but knee was red.It was observed that the suture/suture line had broken/snapped.Skin and external tissue was fine.Deeper tissue needed further repair.The patient required re-operation to repair quad tendon and re-suturing.The re-operation was done on (b)(6) 2020.It is unknown if residual barbed suture was removed.Surgeon re-closed with other type sutures.

Manufacturer Narrative

Date sent to the fda: 09/21/2020.Additional h-6 patient codes: 2091.Additional b5 narrative: incision was closed up beautifully with an exception of a little scab distally.The patient knee was largely swollen.When the patient was opened up, the wound was clean.The surgeon opined that extra weight may have been a factor.They repaired wound with ticron and did a vicryl closure.This report is being submitted pursuant to the provisions of 21 cfr, part 803.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 inc, or its employees that the report constitutes an admission that the product, ethicon inc, 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.

Manufacturer Narrative

Date sent to the fda: 09/28/2020.Additional information was requested, and the following was obtained: the patient demographic info: age, gender, bmi at the time of index procedure? patient was described as being over 300 lbs.With unknown bmi.Did the operating surgeon observe any sutures deficiency or anomaly before or during the suture placement? sutures were described as normal when used at initial time of surgery.How were sutures initially placed (interrupted or continuous)? sutures were placed as per ifu in a continuous fashion, seated tab and 2-3 back passes to lock.How the sutures were initially tied? as per ifu for symmetric.Was the fixation tab seated against the tissue at the initiation of suture use during the index procedure? described as seated per ifu above or adjacent to apex of incision were two reverse stitches performed across the incision prior to closure? surgeon said yes.Were both stratafix sutures removed during re-operation? not completely no.What is physician¿s opinion as to the etiology of or contributing factors to this event? physician says patient stumbled on stairs early on in recovery.Patient did not come in for care for a few weeks post op or post ¿stumble¿.Incision had healed well however internal damage thought due to suture breakage post stumble resulted in reoperation to repair quadricep/tendon displacement/tear.What is the patient current status? stable.The following information was requested, but unavailable: where (termination, middle, end) stratafix sutures broke? other relevant patient comorbidities/concomitant medications? what was the tissue condition, i.E., normal or thin, calcified, fragile, diseased? this report is being submitted pursuant to the provisions of 21 cfr, part 803.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 inc, or its employees that the report constitutes an admission that the product, ethicon inc, 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: STFX SYM PDS+ UNI VIO 24IN 1 S/A CTX
• Type of Device: SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10564655
• MDR Text Key: 208511092
• Report Number: 2210968-2020-07183
• Device Sequence Number: 1
• Product Code: NEW
• UDI-Device Identifier: 10705031245273
• UDI-Public: 10705031245273
• Combination Product (y/n): N
• PMA/PMN Number: K141776
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2020
• 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
• Date Manufacturer Received: 03/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PRINEO SKIN CLOSURE SYSTEM UNKNOWN PRODUCT
• Patient Outcome(s): Required Intervention
• Patient Weight: 136