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

Catalog Number	VCP311H
Medical Device Problem Codes	Break (1069); Product Quality Problem (1506); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 5/8/2025 h6 component code: g07002 - device not returned.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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Additional information was requested, the following was obtained: - it was reported that three vicryl plus sutures broke during suturing, with the needle detaching from the swage, and one suture tying itself open before being secured.Can you clarify if these three issues happened with each of the three devices, or did each problem occur with each suture? ans: the three sutures happened on the same patient.Same procedure.There were three sutures affected.According to what the surgeon mentioned.- please provide the source or name of person providing answers to follow-up questions: ans: sales rep was not present in the case.It was being told by the surgeon himself and he was asking if j&j changed raw material, changed factory etc as this never happened before in his practice.And he is a senior surgeon.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 orthopedic procedure in (b)(6) 2025 and suture was used.It was reported that the orthopaedic surgeon mentioned that there is 3 sutures that broke when he was doing the suturing.The needle detached from the swage, and the suture that he had tied opened on its own and before not secure.There were no patient consequences reported.Additional information was requested.

• Brand Name: VCL+ VIO 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.-GMBH; robert-koch strasse 1; p.o. box 1409; norderstedt ; GM
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 21994990
• Report Number: 2210968-2025-05154
• Device Sequence Number: 8312827
• Product Code: GAM
• UDI-Device Identifier: 10705031052192
• UDI-Public: (01)10705031052192(17)270630(10)UHBDHPW0
• Combination Product (Y/N): Y
• Initial Reporter Country: MY
• 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): 05/09/2025

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 Catalogue Number: VCP311H
• Device Lot Number: UHBDHPW0
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2025
• Initial Report FDA Received Date: 05/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/25/2024
• 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