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

Catalog Number	D10045
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device pam941 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.Additional information was requested and the following was obtained: how many devices had needle pull off issue in this procedure? 2 devices were reported.Device return status/follow up: when we send the sample to you, we will let you know its return date and tracking number.No further information will be provided.Note: events reported via mw 2210968-2019-89380.
Event or Problem Description
It was reported that the patient underwent a total hip replacement surgery on (b)(6) 2019 and suture was used.The suture pulled off from the needle easily during closing of the surgical wound on the muscle layer by interrupted suturing.It was a control release needle.Another package with another lot number was used with no problem.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 11/20/2019.Additional device evaluated by mfr: unopened samples of product code d10045, lot pam941 were received for analysis.This product code is control release and required three strands per packet.During visual inspection of the unopened samples, no defects were found on the packages.Samples were opened and contains three strands; the swage and attachment area of samples were noted to be as expected.The sutures were dispensed without problems and examined along of the strand and no defects or damaged were found.A functional test was performed and the pull force results meet the customer 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 samples received, no performance needle pull off was found, and the tested samples met the finished goods requirements.Representative samples returned to support investigation of 2 device issues captured in reports 2210968-2019-89380.Analysis results have been included in follow-up reports for each.

• 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: 9268402
• Report Number: 2210968-2019-89375
• Device Sequence Number: 19486922
• Product Code: GAM
• UDI-Device Identifier: 10705031134300
• UDI-Public: 10705031134300
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K810428
• 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): 10/07/2019

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: 12/31/2023
• Device Catalogue Number: D10045
• Device Lot Number: PAM941
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2019
• Initial Date Received by Manufacturer: 10/07/2019
• Supplement Date Received by Manufacturer: 11/01/2019
• Initial Report FDA Received Date: 11/01/2019
• Supplement Report FDA Received Date: 11/20/2019
• Patient Sequence Number: 1