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

Model Number	J582G
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device mem697 batch number, 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: it was reported "the nurse used the suture.It is very easy to tear apart" please clarify: please clarify the intra-op event: what does it mean the suture ¿tear apart¿? was this the suture breakage, fraying or pull off (detached from the needle)? fraying what tissue was being approximated or sutured when it broke? no information.What was used to complete the procedure? no information.Procedure name and date? no information.Event date? no information.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 patient underwent an unknown procedure on an unknown date and suture was used.During the procedure, the suture was very easy to tear apart.The suture frayed.There were no adverse patient consequences reported.No additional information was provided.
Additional Manufacturer Narrative
Date sent to the fda: 11/09/2020.Additional information: additional h-3 summary: an empty opened foil, an empty opened folder and five unopened samples of product were received for evaluation.During the visual inspection of five unopened samples, no defects were found on the packages.The samples were opened, and the swage and attachment area were noted to be as expected.The sutures were dispensed without problems and examined along of the strand and no defects, damaged, fraying or suture breakage were noted.The device performed without any defect noted and the actual complaint sample was not returned for analysis.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 27IN 0 S/A XLH
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10643126
• Report Number: 2210968-2020-07735
• Device Sequence Number: 3158517
• Product Code: GAM
• UDI-Device Identifier: 10705031041455
• UDI-Public: 10705031041455
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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
• Report Date (Section B): 09/16/2020

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: 04/30/2023
• Device Model Number: J582G
• Device Catalogue Number: J582G
• Device Lot Number: MEM697
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2020
• Initial Date Received by Manufacturer: 09/16/2020
• Supplement Date Received by Manufacturer: 10/13/2020
• Initial Report FDA Received Date: 10/07/2020
• Supplement Report FDA Received Date: 11/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1