MAUDE Adverse Event Report: ETHICON INC. VCL+ VIO 8X18IN 3-0 S/A SH CR; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	VCP774D
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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.
Event or Problem Description
It was reported that the patient underwent an artificial elbow joint replacement surgery on (b)(6) 2019 and suture was used.During interrupted suturing on the subcutis, after passing the needle through the tissue, the suture was broken easily when pulling the suture.The surgeon opined that strength of sutures with the lot # was weak, another package was used for the patient with no problem.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device lot kl8067, and no non-conformances were identified.

• Brand Name: VCL+ VIO 8X18IN 3-0 S/A SH 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: 9281510
• Report Number: 2210968-2019-89545
• Device Sequence Number: 2801429
• Product Code: GAM
• UDI-Device Identifier: 10705031055513
• UDI-Public: 10705031055513
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 10/09/2019

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: 09/30/2021
• Device Catalogue Number: VCP774D
• Device Lot Number: KL8067
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/09/2019
• Supplement Date Received by Manufacturer: 11/06/2019
• Initial Report FDA Received Date: 11/05/2019
• Supplement Report FDA Received Date: 11/25/2019
• Patient Sequence Number: 1