MAUDE Adverse Event Report: ETHICON INC. VCL UC BRD VIO 12IN 9-0 D/A TG140-8; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	V549G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a blepharoplasty procedure on 03/03/2022 and suture was used.During the procedure, the surgeon was closing the eyelid and pulled it through to tightened and it broke off two different times.A third suture was used to complete the procedure successfully.There were no patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
(b)(4).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 via: what is the lot number? the product was sent out today and the lot number is included in the package.Events reported via: 2210968-2022-02396.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 4/28/2022.H6 component code: g07002 device not returned.H3 investigational summary: an analysis of the product could not be performed since a physical sample was not received for evaluation, only an empty folder and a detached needle from a different product code were received.An evaluation of the manufacturing documentation could not be completed as the lot number was not provided.As part of ethicon's quality process, each batch is randomly visually inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post-market surveillance.If the product is received at a later date, the investigation will be updated as applicable.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 UC BRD VIO 12IN 9-0 D/A TG140-8
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 14021799
• Report Number: 2210968-2022-02397
• Device Sequence Number: 2632950
• Product Code: GAM
• UDI-Device Identifier: 10705031051294
• UDI-Public: 10705031051294
• Combination Product (Y/N): N
• 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,Followup
• Report Date (Section B): 04/28/2022

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 Model Number: V549G
• Device Catalogue Number: V549G
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2022
• Supplement Date Received by Manufacturer: 04/04/2022
• Initial Report FDA Received Date: 04/06/2022
• Supplement Report FDA Received Date: 04/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown