MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD UD 27IN 3 S/A CCS-1; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	J808T
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/26/2020
Type of Reportable Event	Malfunction
Additional 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: what tissue/location was suturing when pull off occurred? linea alba on the abdomen of a horse.How many suture/needle pull offs occurred during suturing on this one patient during this single surgical procedure? it has happened twice.Procedure name: equine colic surgery, date (b)(6) 2020.Was the needle removed from the animal during the same procedure? yes.Note: events reported in 2210968-2020-07242.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that a horse underwent a colic procedure on (b)(6) 2020 and suture was used on the abdomen.During the procedure, the suture pulled off completely at the swage part of the needle.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 09/28/2020.Additional information: h6.A manufacturing record evaluation was performed for the finished device phz839 batch number, and no non-conformances were identified.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 UD 27IN 3 S/A CCS-1
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10574900
• Report Number: 2210968-2020-07243
• Device Sequence Number: 1271029
• Product Code: GAM
• UDI-Device Identifier: 10705031043077
• UDI-Public: 10705031043077
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K022269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2024
• Device Model Number: J808T
• Device Catalogue Number: J808T
• Device Lot Number: PHZ839
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/09/2020
• Supplement Date Received by Manufacturer: 09/28/2020
• Initial Report FDA Received Date: 09/23/2020
• Supplement Report FDA Received Date: 09/28/2020
• Patient Sequence Number: 1