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

Model Number SXPP1A400

Device Problem Break (1069)

Patient Problems Necrosis (1971); Fluid Discharge (2686); Not Applicable (3189)

Event Date 09/24/2020

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 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: age, gender, weight, bmi at the time of index procedure date and indication for index surgical procedure? what was the tissue condition ( i.E., normal or thin, calcified, fragile, diseased) where sutures were used? location of pre-op infection and culture results if any? did the patient receive any antibiotics pre-, intra- or post-operation for existed infection? did the operating surgeon observe any suture deficiency or anomaly before or during the suture placement? product lot numbers for both stratafix sutures (sxpp1a439 and sxpp1a400)? other relevant patient comorbidities/concomitant medications what is physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient current status after re-suturing? if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Events were submitted via 2210968-2020-07775 and 2210968-2020-07777.

Event Description

It was reported that the patient with infection underwent a total hip replacement on unknown date and the barbed suture was used in fascia.The patient came back with oozing and the incision was reopened.The barbed suture was almost absorbed fully.Fragments were just little pieces of suture that surgeon was easily able to pull out them.The surgeon opined that due to the patient¿s infection, a dead space was created in the deep tissue layers and he did not think the sutures were the cause.The patient was re-closed with another like barbed suture.There was 5 weeks from the time of the initial suture implantation to when the incision was reopened and very broken down sutures were found.Additional information has been requested.

Manufacturer Narrative

Date sent to the fda: 11/13/2020.Corrected h-6 patient codes: 2686, 3189- surgical intervention.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 1 S/A CTX
• Type of Device: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10649943
• MDR Text Key: 210436539
• Report Number: 2210968-2020-07777
• Device Sequence Number: 1
• Product Code: NEW
• UDI-Device Identifier: 10705031219366
• UDI-Public: 10705031219366
• Combination Product (y/n): N
• 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: 09/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SXPP1A400
• Device Catalogue Number: SXPP1A400
• 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
• Patient Outcome(s): Required Intervention