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	07/15/2019
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.
Event or Problem Description
It was reported that a patient underwent a total knee replacement on (b)(6) 2019 and suture was used.During the procedure, the needle popped off the suture.There were no patient consequences reported.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device mj5304 batch number, and no non-conformances were identified.

• 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: 8893397
• Report Number: 2210968-2019-85548
• Device Sequence Number: 16534466
• 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): 07/22/2019

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: 07/31/2023
• Device Catalogue Number: VCP719T
• Device Lot Number: MJ5304
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/22/2019
• Supplement Date Received by Manufacturer: 08/20/2019
• Initial Report FDA Received Date: 08/14/2019
• Supplement Report FDA Received Date: 08/27/2019
• Patient Sequence Number: 1