MAUDE Adverse Event Report: ETHICON INC. VCL+ VIO 3X18IN 2 S/A OS-8 CR; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	VCP719T
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint:(b)(4).A manufacturing record evaluation was performed for the finished device lot number me5288, and no non-conformances were identified.Three unopened samples of product code vcp719, lot me5288 were returned for analysis.The product code is control release and required three strands per packet.The complaint sample was not received for evaluation.During the visual inspection of samples, no defects were found on the packages.The samples were opened and contains three strand each.The swage and attachment area of needles 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 results meet the customer requirements.Per the condition of the samples, no performance pull off suture needle was found.Representative samples returned to support investigation of 2 device issues captured in report 2210968-2019-85101 and this 2210968-2019-85154.Analysis results have been included in follow-up reports for each.
Event or Problem Description
It was reported that the patient underwent a total knee replacement procedure on (b)(6) 2019 and the suture was used.It was reported that the pop off suture when being loaded just falls off.There were no patient consequences reported.
Additional Manufacturer Narrative
Representative samples returned to support investigation of 2 device issues captured in report 2210968-2019-85101 and this 2210968-2019-85154.Analysis results have been included in initial reports for each.

• Brand Name: VCL+ VIO 3X18IN 2 S/A OS-8 CR
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8860642
• Report Number: 2210968-2019-85154
• Device Sequence Number: 525478
• Product Code: GAM
• UDI-Device Identifier: 10705031055087
• UDI-Public: 10705031055087
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K032420
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2019

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: 04/30/2023
• Device Catalogue Number: VCP719T
• Device Lot Number: ME5288
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2019
• Initial Date Received by Manufacturer: 07/08/2019
• Supplement Date Received by Manufacturer: 07/08/2019
• Initial Report FDA Received Date: 08/05/2019
• Supplement Report FDA Received Date: 08/05/2019
• Patient Sequence Number: 1