MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD VIO 8X18IN 0 S/A CT-2 CR; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	J727D
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/05/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Attempts are being made to receive a device.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: age, gender, weight, bmi at the time of index procedure? name and/or indication of index surgical procedure? please confirm that three vicryl sutures (j727d) were used to close fascia on each patient? product lot number? what type of fascia and in what body structure located? what was the tissue condition, i.E., normal or thin, calcified, fragile, diseased? how were the sutures placed (interrupted or continuous)? how were the sutures tied (square knot or multiple knots one end)? did the operating surgeon observe any suture deficiency or anomaly before, or during suture placement? please clarify what is meant by the ¿sutures did not hold¿? how was the ¿sutures did not hold¿ observed? were there all three sutures observed with the same issue? was there any precipitating stress factor for ¿sutures did not hold¿? how was the issue fixed during the re-operation? was the re-suturing performed? if yes, what was used for it? other relevant patient history/concomitant medications? what is physician¿s opinion as to the etiology of or contributing factors to these events? what is the patient¿s current status? if applicable, will product be returned, return date, tracking information? 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 2210968-2021-02967, and 2210968-2021-02970.
Event or Problem Description
It was reported that the patient underwent an unknown laparoscopic procedure on (b)(6)2021 and the suture was used to close the fascia.It was reported that the suture did not hold, and the patient was brought back to fix issue.Additional information has been requested.
Additional Manufacturer Narrative
Date sent to the fda: 05/20/2021.A manufacturing record evaluation was performed for the finished device lot number qbmekb /j727d05, and no non-conformances related to the reported complaint condition were identified.Additional h6 component code: g07002 ¿ conforming device.Additional h-3 summary: visual inspection and functional test evaluation were conducted on the returned device.Visual analysis of the returned sample determined that twenty-eight unopened samples of product code j727d were received for evaluation.The product is multistrand count and each folder contains eight strands.Visual inspection of unopened samples and no defects were found on the packages.The samples were opened, and the swage and attachment area were noted to be as expected.The sutures were dispensed without problems and examined along the strand and no defects, damage, untying suture knots or suture breakage were noted.A functional test was performed using an instron and the tensile strength force was above the minimum requirement.The event described could not be confirmed as the device performed without any defect noted.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: 05/20/2021.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: VCL CT BRD VIO 8X18IN 0 S/A CT-2 CR
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 11606594
• Report Number: 2210968-2021-02968
• Device Sequence Number: 4216001
• Product Code: GAM
• UDI-Device Identifier: 10705031042582
• UDI-Public: 10705031042582
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K022269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2025
• Device Model Number: J727D
• Device Catalogue Number: J727D
• Device Lot Number: QBMEKB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2021
• Initial Date Received by Manufacturer: 03/22/2021
• Supplement Date Received by Manufacturer: 05/12/2021
• Initial Report FDA Received Date: 04/01/2021
• Supplement Report FDA Received Date: 05/20/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention