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

Model Number	VCP741D
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).This is a combination product, and the event has been reviewed for both the suture and the triclosan.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.What procedure type was being performed for each event in which suture pull off occurred? can you please confirm if the event of suture pull off occurred twice in each separate procedure? has product been returned? a manufacturing record evaluation was performed for the finished device batch, and no non-conformance's were identified.The device upon which this medwatch is based has been received, however, the product evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.Trade name: irgacare, active ingredient(s): triclosan, dosage form: suture/solid/parenteral, strength: 275 g/m.Related events captured via 2210968-2021-06279.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date in 2021 and suture was used.While passing the needle into the fascia, the needle came out empty and the suture came off in the fascia before the doctor popped it off.This occurred on the third pass of the suture.The procedure was delayed by five minutes, but successfully completed using a new like device.There were no patient consequences.Additional information has been requested.
Additional Manufacturer Narrative
Date sent to the fda: 08/06/2021.A manufacturing record evaluation was performed for the finished device rc2ddm and no non conformances / manufacturing irregularities related to the malfunction were identified.Additional h6 component code: g07002 ¿ reported condition not confirmed.Additional h-3 summary: a winding former and two dispensed needle-suture of product code vcp741d were returned for analysis.The product code is control release and required eight strands per packet.In order to evaluate the conditions of the returned sample, the swage and attachment area were noted to be as expected.The suture was examined along of the strand to detect any issue related no defects were observed during evaluation.Functional test was performed, and the pull force meet requirements.Additional information was requested, and the following was obtained: what procedure type was being performed for each event in which suture pull off occurred? spine procedure.Can you please confirm if the event of suture pull off occurred twice in each separate procedure? - yes, i was told the different sutures from the same box were used on different cases.It has happened in a different cases.Has product been returned? - yes.This report is being submitted pursuant to the provisions of 21 cfr, part 803, part 4 subpart b.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: VCL+ VIO 8X18IN 1 S/A CT-1 CR
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12163152
• Report Number: 2210968-2021-06278
• Device Sequence Number: 4131192
• Product Code: GAM
• UDI-Device Identifier: 10705031055216
• UDI-Public: 10705031055216
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K032420
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2021

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: 02/28/2026
• Device Model Number: VCP741D
• Device Catalogue Number: VCP741D
• Device Lot Number: RC2DDM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2021
• Initial Date Received by Manufacturer: 06/17/2021
• Supplement Date Received by Manufacturer: 07/14/2021
• Initial Report FDA Received Date: 07/13/2021
• Supplement Report FDA Received Date: 08/06/2021
• Patient Sequence Number: 1