MAUDE Adverse Event Report: ETHICON INC. VCL+ UD 27IN 3-0 S/A SH-1; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	VCP219H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Device not returned.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.Sample analysis: visual analysis of the returned sample determined that one empty winding former, a paper lid and a needle product code vcp219h were received to ethicon for evaluation.The product code is single-armed and on the needle, the swage and attachment area were noted to be as expected, marks by the surgical instrument were noted on body needle and no suture remnant could be observed into the barrel hole.The suture was not received for evaluation to determine the assignable cause.As part of our quality process, the manufacturing records of this lot-serial number were reviewed, and the manufacturing standards were met prior to the release of this batch.No conclusion could be reached as to what caused the reported complaint.As part of ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Trade name: irgacare®, active ingredient(s): triclosan, dosage form: suture/solid/parenteral, strength: = 2360 g/m.
Event or Problem Description
It was reported that a patient underwent a thyroidectomy surgery on (b)(6) 2022 and suture was used.During the procedure, the reported suture detached from the swaged end of the needle during usage.No adverse patient consequences were reported.Additional information was requested.

• Brand Name: VCL+ UD 27IN 3-0 S/A SH-1
• 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; cuidad juarez ; MX
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 15015417
• Report Number: 2210968-2022-05471
• Device Sequence Number: 15139411
• Product Code: GAM
• UDI-Device Identifier: 10705031051720
• UDI-Public: 10705031051720
• Combination Product (Y/N): Y
• Initial Reporter Country: HK
• PMA/510(K) Number: K132580
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/14/2022

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: VCP219H
• Device Catalogue Number: VCP219H
• Device Lot Number: SBMCAH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2022
• Initial Report FDA Received Date: 07/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/04/2022
• 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