MAUDE Adverse Event Report: ETHICON INC. VCL+ UD 18IN 4-0 S/A PS-2 PRM MP; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	VCP496H
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).The product 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.Note: events reported via mw# 2210968-2021-01127, 2210968-2021-01129.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that the patient underwent wound closure on an unknown date and suture was used.During the procedure the thread broke off the needle.There were no adverse patient consequences reported.
Additional Manufacturer Narrative
Date sent to the fda: 03/03/2021.This is a combination product, and the event has been reviewed for both the suture and the triclosan.Trade name - irgacare® active ingredient(s) ¿ triclosan.Dosage form ¿ suture/solid/parenteral.Strength = 275 g/m.Additional information: d4, h4, h6.A manufacturing record evaluation was performed for the finished device vcp496h; pgbcbdx0 number, and no non-conformances were identified.Additional h-3 summary: visual analysis of the returned sample determined that one opened sample of product code vcp496 was received for evaluation.Clip off defect could be observed in the sample.The visual inspection concluded that the needle detached from the suture, the barrel hole was examined, and remnant suture was noted, the suture end is severely cut.The functional test could not be performed.The clip off defect has been correlated to the manufacturing process.This defect is caused by excessive pressure on the suture during swaging of the needle and consequently breaking.Based on the information currently available, the clip off was identified during the investigation of the sample received.This product issue will be addressed through ethicon inc¿s quality system.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+ UD 18IN 4-0 S/A PS-2 PRM MP
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 11297897
• Report Number: 2210968-2021-01126
• Device Sequence Number: 729205
• Product Code: GAM
• UDI-Device Identifier: 10705031053786
• UDI-Public: 10705031053786
• Combination Product (Y/N): Y
• 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,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2021

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: 05/31/2022
• Device Model Number: VCP496H
• Device Catalogue Number: VCP496H
• Device Lot Number: PGBCBDX0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2021
• Initial Date Received by Manufacturer: 01/15/2021
• Supplement Date Received by Manufacturer: 02/10/2021
• Initial Report FDA Received Date: 02/08/2021
• Supplement Report FDA Received Date: 03/03/2021
• Patient Sequence Number: 1