MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD VIO 27IN 4-0 S/A FS-2; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	J397H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device batch qd2ahl, j397h50 and no non-conformances were identified.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.Additional information was requested, and the following was obtained: did the vet doctor note any quality issue with the ethicon suture before use/ during suturing/ post-op examination or during post op intervention.? no obvious product defect observed at time of procedure.Could you please confirm which of the 3 patients presented a broken suture post-op? the broken suture was observed on the third patient: patient c (b)(4).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 cat underwent a spay procedure on (b)(6) 2021 and the suture was used.There was no obvious product defect observed at time of procedure.On post- op day 6, the suture broke.

• Brand Name: VCL CT BRD VIO 27IN 4-0 S/A FS-2
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 11386871
• Report Number: 2210968-2021-01818
• Device Sequence Number: 3742517
• Product Code: GAM
• UDI-Device Identifier: 10705031039575
• UDI-Public: 10705031039575
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/05/2021

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: 03/31/2025
• Device Model Number: J397H
• Device Catalogue Number: J397H
• Device Lot Number: QD2AHL
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2021
• Initial Report FDA Received Date: 02/26/2021
• Patient Sequence Number: 1