MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD VIO 27IN 2-0 S/A UR-6; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	J602H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an appendectomy procedure on (b)(6) 2024 and suture was used.On (b)(6) 2024, at approximately 12:24 pm, the pharmacy satellite team at ot reported an incident where the suture detached from the needle body when attempting to use the suture during a vla operation by the operator.There were no patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 9/10/2024.H6 component code: g07002 - device not returned.This report is being submitted pursuant to the provisions of 21 cfr.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.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: were there any unexpected outcomes or complications as a result of the prolonged surgery time? was there any change in the patient¿s post-operative care due to the prolonged procedure? please perform and document the follow up attempt for product return.Please document the shipment tracking number in notes or rmao sections.Please provide the source or name and title of external person providing answers to follow-up (external person submitting answers to sales rep or loc/bq) the following information was reported: was surgery delayed due to the reported event? : yes, if yes, number of minutes: : 10 minute, action taken when event occurred? : replace product with new product , was procedure successfully completed? : yes, were fragments generated? : unknown, if yes, were they removed easily without additional intervention? : unknown, patient status/ outcome / consequences : , patient consequence description/was there a clinical outcome experienced by the patient (infection, inflammation, etc.)?: nothing, was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: : unknown, is the patient part of a clinical study : unknown.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.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.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 inc, or its employees that the report constitutes an admission that the product, ethicon inc 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.Additional information: h6, d9, h3.H3 investigation summary: the product was returned to ethicon for evaluation.One empty foil, a detached needle and one suture were received for analysis.The product code is j602h.Upon a visual inspection of the detached needle, the swage and attachment area were noted to be as expected.The barrel hole of the needle was examined with magnification, and no suture remnant was observed.The suture was examined, and the mark was found to be not according to the process specification causing a short insertion defect.Based on the information currently available, short insertion issue was identified as pull out during the investigation of the sample received.This product issue will be addressed through the ethicon quality system.

• Brand Name: VCL CT BRD VIO 27IN 2-0 S/A UR-6
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; calle durango #2751; ciudad juarez 32575 ; MX 32575
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 20181113
• Report Number: 2210968-2024-09439
• Device Sequence Number: 8696051
• Product Code: GAM
• UDI-Device Identifier: 10705031041615
• UDI-Public: (01)10705031041615(17)281130(10)TPMDDC
• Combination Product (Y/N): N
• Initial Reporter Country: ID
• PMA/510(K) Number: K022269
• 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,Followup
• Report Date (Section B): 06/12/2025

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: J602H
• Device Lot Number: TPMDDC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2024
• Supplement Date Received by Manufacturer: 05/15/2025
• Initial Report FDA Received Date: 09/10/2024
• Supplement Report FDA Received Date: 06/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/08/2023
• 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