MAUDE Adverse Event Report: ETHICON INC. VCL+ VIO 27IN 1 S/A CP; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	VCP480H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Additional information was requested, and the following was obtained: what was used to complete the procedure? a new suture from the same box.Procedure and event date? (b)(6) 2020.Lot number? plbgkk50.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 a patient underwent a joint procedure on (b)(6) 2020; and a suture was used.During the procedure, the suture was torn while suturing the deep dermal layer at wound closure stage.Another like device was used to complete the procedure.There were no adverse patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Date sent to the fda: 09/18/2020.Corrected information : d4 additional information: d4, d10, g1, h4, h6.A manufacturing record evaluation was performed for the finished device vcp480h; plbgkks0 number, and no non-conformances were identified.Additional h-3 summary: rep sample: one unopened sample of product code vcp480, lot plbkks0 was received for analysis.The complaint sample was not returned for evaluation.During the visual inspection of the sample, no defects were found on the package.The sample was opened, and the swage and attachment area were noted to be as expected.The suture was dispensed without problems and examined along of the strand and no defects, damaged or suture breakage were observed.A functional test was performed and the tensile strength force was above the minimum requirement.The device performed without any difficulties noted.Photo: one picture was provided for analysis.Upon visual inspection of the picture, a foil appears to be sealed of product code vcp840, lot plbgkks0 could be observed.However, no conclusion could be reach on the issue reported as the suture is not visible at the photo and the sample was not returned for analysis.There is evidence of a complete seal present on the packaging.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+ VIO 27IN 1 S/A CP
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10449289
• Report Number: 2210968-2020-06350
• Device Sequence Number: 14366499
• Product Code: GAM
• UDI-Device Identifier: 10705031053595
• UDI-Public: 10705031053595
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K032420
• 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): 08/13/2020

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: 09/01/2022
• Device Model Number: VCP480H
• Device Catalogue Number: VCP480H
• Device Lot Number: PLBGKKS0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2020
• Initial Date Received by Manufacturer: 08/13/2020
• Supplement Date Received by Manufacturer: 08/26/2020
• Initial Report FDA Received Date: 08/25/2020
• Supplement Report FDA Received Date: 09/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1