MAUDE Adverse Event Report: ETHICON INC. SFX SYM PDS+ UNI VIO 18IN 0 S/A CT-1; SUTURE, SURGICAL, ABSORBABLE

Model Number SXPP1A401

Device Problems Break (1069); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Wound Dehiscence (1154); Fluid Discharge (2686)

Event Date 12/02/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).To date the device has not been returned.If the device or further details are received at the later date a supplemental medwatch will be sent.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.The patient demographic info: bmi at the time of index procedure.The diagnosis and indication for the index surgical procedure.What tissue was the suture placed? what was the tissue condition, i.E., normal or thin, calcified, fragile diseased? was the fixation tab seated against the tissue at the initiation of suture use during the index procedure? were two reverse stitches performed across the incision prior to closure? please clarify what is meant by ¿improper length of backstitch¿? what date did the joint leakage occur (how many days post-op)? what date was dehiscence found? what tissue dehisced? was there any precipitating stress factor for the sutures pulling out of the tissue? what was the appearance of the suture during the second procedure? did the suture pull out of the tissue or did the suture break post-operatively? if the suture broke, where did the suture break (termination, middle, end)? other relevant patient history/concomitant medications lot number? if applicable, will product be returned, return date, tracking information.What is the physician¿s opinion as the etiology of or contributing factors to this event? what is the patient¿s current status? additional information was requested, and the following was obtained: the patient¿s initials - (b)(6).Seriousness - not serious.The reason of the seriousness - it was judged from the condition as of (b)(6).Surgeon¿s opinion about causal relationship between product and event - there was causal relationship between the product and event.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported that the patient underwent a right knee artificial joint replacement surgery on (b)(6) 2020 and the barbed suture was used.The incision was made by the parapatellar approach.Suturing was started from the foot side using the barbed suture.At the beginning of suturing, a cross stitch after one back stitch was made based on the recommended measure.Then, continuous suturing was performed.As for the cephalic side, the quadriceps and vastus medialis were sutured.Then, back stitches were put with the rest of the sutures about 5-6 cm.No reinforcement was done on the head side on the quadriceps and vastus medialis.After the surgery, joint fluid leakage was observed.On (b)(6), the wound dehiscence was noticed.On (b)(6) 2020, a reoperation was performed under local anesthesia, and the tissue of the affected site was repaired.All the affected surgical wound dehisced.The patient has been hospitalized and is currently under observation, and the affected site has been fixed with an orthosis.No infection observed.The surgeon opined that there was causal relationship between the product and event.The surgeon also opined that other contributing factor is reinforcement was done on the foot side only, and no reinforcement was done on the head side of the wound and improper length of the backstitch.Additional information has been requested.

Manufacturer Narrative

Date sent to the fda: 01/05/2021.Additional h6 component code: g07002 ¿ device not returned.The following information was requested, but unavailable: what was the tissue condition, i.E., normal or thin, calcified, fragile diseased? was the fixation tab seated against the tissue at the initiation of suture use during the index procedure? what date did the joint leakage occur (how many days post-op)? what tissue dehisced? was there any precipitating stress factor for the sutures pulling out of the tissue? if the suture broke, where did the suture break (termination, middle, end)? other relevant patient history/concomitant medications lot number? what is the physician¿s opinion as the etiology of or contributing factors to this event? additional information was requested, and the following was obtained: the diagnosis and indication for the index surgical procedure.Right knee artificial joint replacement surgery.What tissue was the suture placed? suturing was started from the foot side using stratafix symmetric.At the beginning of suturing, a cross stich after one back stich was made based on the recommended measure.Then, continuous suturing was performed.As for the cephalic side, the quadriceps and vastus medialis were sutured.Then, back stitches were put with the rest of the sutures (about 5-6 cm.) as for the foot side, reinforcement was done by a few stitches with 0 pds plus.No reinforcement was done on the head side (on the quadriceps and vastus medialis.) were two reverse stitches performed across the incision prior to closure?- at the beginning of suturing, a cross stich after one back stich was made based on the recommended measure, and back stitches were put with the rest of the sutures (about 5-6 cm).Please clarify what is meant by ¿improper length of backstitches¿? back stitches were put with the rest of the sutures (about 5-6 cm).What date was dehiscence found? on (b)(6).What was the appearance of the suture during the second procedure? -the surgeon's comment: short sutures were observed in two places during the reoperation, but no other suture were visible.The tissue was torn laterally to the incision and it was difficult to suture when repairing.Did the suture pull out of the tissue or did the suture break post-operatively? - suture broke post-operatively.The suture was removed and re-sutured with another suture during the reoperation.If applicable, will product be returned, return date, tracking information - no sample will be returned.What is the patient¿s current status? the patient is being followed up for 2 weeks with the brace fixed.She is stable without infection.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.Date sent to the fda: 01/05/2021.Corrected h6- medical device problem code: a0401.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: SFX SYM PDS+ UNI VIO 18IN 0 S/A CT-1
• Type of Device: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 11088332
• MDR Text Key: 226266699
• Report Number: 2210968-2020-10367
• Device Sequence Number: 1
• Product Code: NEW
• UDI-Device Identifier: 10705031219342
• UDI-Public: 10705031219342
• Combination Product (y/n): Y
• PMA/PMN Number: K113004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 12/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: SXPP1A401
• Device Catalogue Number: SXPP1A401
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/04/2021
• Patient Sequence Number: 1
• Treatment: PDS LL PLUS ANTIBACTERIAL SUTURE UNKNOWN PRODUCT
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR
• Patient Weight: 34