MAUDE Adverse Event Report: ETHICON INC. VCL+ UD 27IN 3-0 S/A FS-2; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	VCP423H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Additional information was requested and the following was obtained: was surgery delayed due to the reported event? unknown, action taken when event occurred? new suture was picked from the box, was procedure successfully completed? yes, were fragments generated? unknown, if yes, were they removed easily without additional intervention? unknown, patient status/ outcome / consequences: no, was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: unknown, device evaluation : it was reported performance pull off - suture needle.An empty open box and an open box with thirty-six unopened samples of product code (b)(4), lot # pdbdtps0 were returned for analysis.During the visual inspection of thirteen 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, or damaged 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 conditions of the sample received, no performance detached needle was found, and the tested sample met the finished goods requirements.
Event or Problem Description
It was reported that a patient underwent a breast implant procedure on (b)(6) 2019 and suture was used.The suture loosed from the needle during the procedure.Additional information was requested.No adverse patient consequences were reported.
Additional Manufacturer Narrative
Date sent to the fda: 02/12/2020.A manufacturing record evaluation was performed for the finished device vcp423h; pdbdtps0 number, and no non-conformances were identified.Corrected h-3 summary: an empty open box and an open box with thirty-six unopened samples of product code vcp423, lot # pdbdtps0 were returned for analysis.During the visual inspection of thirteen 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, or damaged were observed.A functional test was performed using an instron and the pull force were above the minimum requirements.Per the conditions of the sample received, no performance pull off - suture needle was found, and the tested sample met the finished goods requirements.

• Brand Name: VCL+ UD 27IN 3-0 S/A FS-2
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9599485
• Report Number: 2210968-2020-00437
• Device Sequence Number: 546527
• Product Code: GAM
• UDI-Device Identifier: 10705031053113
• UDI-Public: 10705031053113
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K032420
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2019

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: 03/31/2022
• Device Model Number: VCP423H
• Device Catalogue Number: VCP423H
• Device Lot Number: PDBDTPS0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2020
• Initial Date Received by Manufacturer: 12/18/2019
• Supplement Date Received by Manufacturer: 01/20/2020
• Initial Report FDA Received Date: 01/16/2020
• Supplement Report FDA Received Date: 02/12/2020
• Patient Sequence Number: 1