MAUDE Adverse Event Report: ETHICON INC. VCL+ VIO 8X18IN 3-0 S/A RB-1 CR; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	VCP713D
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Attempts have been 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 a patient underwent an unknown neurosurgery on (b)(6) 2020 and suture was used.During the procedure, the suture was detached from the needle easily during interrupted suturing.There were no adverse consequences to the patient.No additional information was provided.
Additional Manufacturer Narrative
(b)(4) date sent to the fda: 05/08/2020.Additional h-3 summary: it was reported performance pull off suture needle.An empty winding former, eight used needles of product code vcp713d were received for evaluation, this product code is control release multistrand and each packet contains eight strands.During the visual inspection of eight used needles, the swage and attachment area were noted to be as expected and marks could be observed on the body needles that appear to be by use of a surgical instrument.No suture remnant was observed into the barrel hole.Sutures were not received for evaluation to determine the assignable cause.The manufacturing records couldn't be reviewed as the batch number is unknown.Per the sample condition, it could not be determined what may have caused the reported incident.Additional information was requested, and the following was obtained: how many needle/sutures pull offs occurred during this single procedure/one patient? the sales rep reported 1 needle-suture.When did the pull off occur? pre-op or during use on the patient? during use.Please clarify if it is still only one needle/suture pull off occurred during use.The sales rep reported 1 needle-suture.

• Brand Name: VCL+ VIO 8X18IN 3-0 S/A RB-1 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: 9929228
• Report Number: 2210968-2020-02666
• Device Sequence Number: 3218380
• Product Code: GAM
• UDI-Device Identifier: 10705031054998
• UDI-Public: 10705031054998
• 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): 03/10/2020

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 Model Number: VCP713D
• Device Catalogue Number: VCP713D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2020
• Initial Date Received by Manufacturer: 03/10/2020
• Supplement Date Received by Manufacturer: 04/20/2020
• Initial Report FDA Received Date: 04/06/2020
• Supplement Report FDA Received Date: 05/08/2020
• Patient Sequence Number: 1