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

Model Number SXPP1A300

Device Problem Break (1069)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 09/18/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional information was requested, and the following was obtained: what tissue was being approximated or sutured when it broke? no further information is available.Was the fixation tab intact when the suture was placed in the patient? no further information is available.Were any missing barbs of suture noted during visual inspection or during use on patient? no further information is available.Did the barbs fail to engage in the tissue? no further information is available.Attempts have been made to retrieve the device.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.

Event Description

It was reported that a patient underwent an orthopedic procedure on (b)(6) 2020; and a barbed suture was used.During the procedure, the suture broke when pulling for would closure.Another like device was used to complete the procedure.There were no adverse patient consequences reported.Additional information was requested.

Manufacturer Narrative

(b)(4).Date sent to the fda: 10/20/2020 corrected h6 patient code: 2645 corrected information: b1, h1 ¿ it was reported that this device is not malfunction reportable.Therefore, this medwatch report 2210968-2020-07379 is not reportable.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 CTXB
• Type of Device: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10593017
• MDR Text Key: 208756764
• Report Number: 2210968-2020-07379
• Device Sequence Number: 1
• Product Code: NEW
• UDI-Device Identifier: 10705031219359
• UDI-Public: 10705031219359
• 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
• Report Date: 09/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SXPP1A300
• Device Catalogue Number: SXPP1A300
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1