MAUDE Adverse Event Report: ETHICON INC. VCL+ VIO 3X18IN 2 S/A CTXB CR; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	D10045
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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.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.The following information was requested, but unavailable: how many of the total quantity were actually involved for the reported issue? 2nd device return follow up.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and the suture was used.During surgery, the suture was detached from the needle more easily than usual.It was a control release needle.There were no adverse patient consequences reported.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 4/27/2020.Additional h3 investigation summary: it was reported performance pull off - suture needle.It was received for analysis an opened box with thirteen unopened samples of product code d10045, lot plz536.This product code is control release and required three strands per packet.During the visual inspection of thirteen 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 strands and no defects were observed.A functional test was performed and the pull force 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, no performance pull off suture needle was found, and the tested samples met the finished goods requirements.

• Brand Name: VCL+ VIO 3X18IN 2 S/A CTXB CR
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9845814
• Report Number: 2210968-2020-02171
• Device Sequence Number: 16876228
• Product Code: GAM
• UDI-Device Identifier: 10705031134300
• UDI-Public: 10705031134300
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K132580
• 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): 02/24/2020

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: D10045
• Device Catalogue Number: D10045
• Device Lot Number: PLZ536
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2020
• Initial Date Received by Manufacturer: 02/24/2020
• Supplement Date Received by Manufacturer: 04/06/2020
• Initial Report FDA Received Date: 03/17/2020
• Supplement Report FDA Received Date: 04/27/2020
• Patient Sequence Number: 1