MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD VIO 36IN 1 S/A CTX; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	J371H
Medical Device Problem Codes	Material Frayed (1262); Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device pmz887 batch number, and no non-conformances were identified.Attempts are being 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 an unknown procedure on (b)(6) 2020 and suture was used.During the procedure, the suture frayed at the swage and detached from the needle at the swage.A like device was used to complete the procedure with no delay in the surgery.There were no adverse patient consequences reported.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 04/14/2020.Additional information: investigation summary: it was reported performance pull off - suture needle and performance fraying suture intra-op.Unopened samples were returned for analysis.The complaint sample was not received.During the visual inspection of six unopened samples, no defects were found on the packages.The samples were opened, and 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, fraying or damages were observed.A functional test was performed and the pull force results were above the minimum requirements.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Per the condition of the samples received, no performance pull off - suture needle or performance fraying suture was found.

• Brand Name: VCL CT BRD VIO 36IN 1 S/A CTX
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9842175
• Report Number: 2210968-2020-02145
• Device Sequence Number: 19492200
• Product Code: GAM
• UDI-Device Identifier: 10705031039391
• UDI-Public: 10705031039391
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 02/21/2020

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: 10/31/2024
• Device Model Number: J371H
• Device Catalogue Number: J371H
• Device Lot Number: PMZ887
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2020
• Initial Date Received by Manufacturer: 02/21/2020
• Supplement Date Received by Manufacturer: 03/19/2020
• Initial Report FDA Received Date: 03/17/2020
• Supplement Report FDA Received Date: 04/14/2020
• Patient Sequence Number: 1