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	08/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device lot phz839, and no non-conformances were identified.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.Additional information was requested, and the following was obtained: what tissue/location was suturing when pull off occured? linea alba on the abdomen of a horse.Did a suture needle pull off occurred with all 9 devices returned during this single procedure? no, it has happened once.There are 9 unopened packages of suture left in this box.How many suture/needle pull offs occurred during suturing on this one patient during this single surgical procedure? it has happened once.Procedure name: equine colic surgery.Date: (b)(6) 2020.Was the needle removed from the animal during the same procedure? yes.
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.

• 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: 10574891
• Report Number: 2210968-2020-06914
• Device Sequence Number: 11080369
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/02/2020

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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/02/2020
• Initial Report FDA Received Date: 09/23/2020
• Patient Sequence Number: 1