MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD VIO 36IN 3-0 S/A V-34; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	J516H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device lot, 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: was surgery delayed due to the reported event? unknown, was procedure successfully completed? unknown, were fragments generated? unknown, if yes, were they removed easily without additional intervention? unknown, patient status/ outcome / consequences.Unknown, was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: unknown.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: what was the initial procedure? what is the procedure date?.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2020 and suture was used.This suture was very easy to break.There were no adverse patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
(b)(4) date sent to the fda: 07/20/2020 additional information was requested and the following was obtained: 1.What was the initial procedure? not available 2.What is the procedure date? not available 3.Will the product be returned for investigation? no.It was discarded by customer.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.Were there any adverse patient consequences reported? 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.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 08/11/2020.Additional information was requested and the following was obtained: were there any adverse patient consequences reported? no patient consequence was reported by customer.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 36IN 3-0 S/A V-34
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10136571
• Report Number: 2210968-2020-04471
• Device Sequence Number: 14058651
• Product Code: GAM
• UDI-Device Identifier: 10705031040830
• UDI-Public: 10705031040830
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K022269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/02/2020

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: 09/30/2024
• Device Model Number: J516H
• Device Catalogue Number: J516H
• Device Lot Number: PL2766
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/02/2020
• Supplement Date Received by Manufacturer: 07/08/2020; 08/05/2020
• Initial Report FDA Received Date: 06/10/2020
• Supplement Report FDA Received Date: 07/20/2020; 08/11/2020
• Patient Sequence Number: 1