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

Model Number	VCP569H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.What is the event day and procedure date? please confirm how many devices were involved in the event? if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that a patient underwent an orthopedic uni knee procedure on an unknown date and suture was used.During the procedure, the suture came out of the swage.Repeated and the case was finished with same suture of a different lot number.The procedure was completed successfully with no adverse patient consequences.Additional information has been requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 07/23/2020 corrected information: b3 a manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Additional information: d4, h4, h6 - method codes additional b5 narrative: it was reported that a patient underwent an orthopedic uni knee procedure on 6/23/2020 and suture was used.During the procedure, the suture came out of the swage.Repeated and the case was finished with same suture of a different lot number.The procedure was completed successfully with no adverse patient consequences.Adverse events will be submitted via 2210968-2020-05110, 2210968-2020-05509, 2210968-2020-05510, and 2210968-2020-05511.Additional information was requested and the following was obtained: response to additional information request from jjm rep - what is the event day and procedure date?date of event 23rd june - please confirm how many devices were involved in the event? 4 each involved 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, 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+ UD 27IN 1 S/A CPX
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10242678
• Report Number: 2210968-2020-05110
• Device Sequence Number: 811941
• Product Code: GAM
• UDI-Device Identifier: 10705031054196
• UDI-Public: 10705031054196
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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): 06/23/2020

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: VCP569H
• Device Catalogue Number: VCP569H
• Device Lot Number: PMZ374
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/23/2020
• Supplement Date Received by Manufacturer: 07/08/2020
• Initial Report FDA Received Date: 07/07/2020
• Supplement Report FDA Received Date: 07/23/2020
• Patient Sequence Number: 1