MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD VIO 18IN 6-0 D/A TG100-8; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	J544G
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Attempts are being made to obtain 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.Name and date of the procedure? event date? was the needle removed from the patient during the same procedure? was there any patient consequence or injury? what is the condition of the patient? what tissue/location was suturing when pull off occurred? were there any unexpected outcomes or complications as a result of this suture needle pull off event? 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.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and suture was used.During the procedure, the suture was detached from the needle.There were no adverse patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 10/26/2020.A manufacturing record evaluation was performed for the finished device lot number an3033, and no non conformances / manufacturing irregularities were identified.Additional information was requested and the following was obtained: name and date of the procedure? horizontal strabismus - monocular.Date: (b)(6) 2020.Date of the event? (b)(6) 2020.The questions below do not apply due to not having reached the patient.Was the needle removed from the patient during the same procedure? was there any consequence or injury to the patient? what is the patient's condition? what tissue / location was suturing when the removal occurred? were there any unexpected results or complications as a result of this suture needle withdrawal event?" 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 18IN 6-0 D/A TG100-8
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10547792
• Report Number: 2210968-2020-07040
• Device Sequence Number: 1270689
• Product Code: GAM
• UDI-Device Identifier: 10705031041073
• UDI-Public: 10705031041073
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K022269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• 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: 02/28/2025
• Device Model Number: J544G
• Device Catalogue Number: J544G
• Device Lot Number: AN3033
• 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: 09/17/2020
• Supplement Report FDA Received Date: 10/26/2020
• Patient Sequence Number: 1