MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD VIO 27IN 5-0 S/A RB-1; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	J303H
Medical Device Problem Codes	Break (1069); Material Frayed (1262); Material Separation (1562)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2019
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that the patient underwent esophageal surgery on (b)(6) 2019 and suture was used.During the procedure, the suture thread broke, fraying completely and the assembly between the thread and the needle was detached.There were no adverse patient consequences reported.
Additional Manufacturer Narrative
(b)(4).Attempts have been made to retrieve the device.To date the device has not been returned.Additional information was requested and the following was obtained.If the device or further details are received at a later date a supplemental medwatch will be sent.The suture has not yet been withdrawn from the hospital by the external transportation.Today they were reminded of it.A manufacturing record evaluation was performed for the finished device am1907 number, and no non-conformances were identified.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 6/28/2021.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.H6 component code: g07002: no device problem found.H3 investigation summary: eighteen packets of product code j303 were returned for analysis with the packaging closed.Upon initial inspection to the samples no external damages were observed on the eighteen packets.In order to evaluate the conditions of the returned samples, thirteen packets were opened, and no defects were detected.The swage and attachment area were noted to be as expected.The sutures were dispensed without problems and examined along of the strand to detect any issue related to fraying, damaged or breakage suture and no defects were observed during evaluation.Functional test was performed, and the pull force and tensile strength were above the minimum requirements.As part of our quality process, the manufacturing records of this lot-serial number were reviewed, and the manufacturing standards were met prior to the release of this batch.It should be noted that as part of our quality process, each batch is randomly inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.There may have been other circumstances or issues that occurred during the use of the device that we were unable to duplicate during our laboratory analysis.

• Brand Name: VCL CT BRD VIO 27IN 5-0 S/A RB-1
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9423460
• Report Number: 2210968-2019-90608
• Device Sequence Number: 1711789
• Product Code: GAM
• UDI-Device Identifier: 10705031038592
• UDI-Public: 10705031038592
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/13/2019

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: 04/30/2024
• Device Model Number: J303H
• Device Catalogue Number: J303H
• Device Lot Number: AM1907
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2021
• Initial Date Received by Manufacturer: 11/13/2019
• Supplement Date Received by Manufacturer: 12/12/2019; 06/02/2021
• Initial Report FDA Received Date: 12/06/2019
• Supplement Report FDA Received Date: 12/20/2019; 06/28/2021
• Patient Sequence Number: 1