MAUDE Adverse Event Report: ETHICON INC. VCL+ UD 27IN 2-0 S/A FSL; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	VCP589H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).This is a combination product, and the event has been reviewed for both the suture and the triclosan.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.(b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.If further details are received at a later date a supplemental medwatch will be sent.Trade name irgacare®.Active ingredient(s) triclosan.Dosage form suture/solid/parenteral.Strength = 275 g/m.Associated events submitted via mw# 2210968-2022-05789, 2210968-2022-05790, 2210968-2022-05791, 2210968-2022-05792, and 2210968-2022-05794.
Event or Problem Description
It was reported that a patient underwent a total hip replacement closure procedure on (b)(6)2022 and the suture was used.During surgery, while using the suture to close the fat layer, the suture and needle became disconnected.It was unknown if the suture broke close to the needle or the needle fell off the suture.The needle was retrieved and no fragments were left in the patient.The surgery was delayed ten minutes.A like device was used to successfully complete the procedure.There were no adverse patient consequences reported.Additional information was requested.

• Brand Name: VCL+ UD 27IN 2-0 S/A FSL
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; avenida de las torres 7125; col salvacar; ciudad juarez 32604 ; MX 32604
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 15081312
• Report Number: 2210968-2022-05793
• Device Sequence Number: 4055466
• Product Code: GAM
• UDI-Device Identifier: 10705031054288
• UDI-Public: 10705031054288
• Combination Product (Y/N): Y
• Initial Reporter Country: AS
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/22/2022

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: VCP589H
• Device Catalogue Number: VCP589H
• Device Lot Number: RMMHUR
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2022
• Initial Report FDA Received Date: 07/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/13/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown