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

Catalog Number	J324H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).H6.Component code: g07002 - device not returned.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 information was requested, and the following was obtained: no patient consequence, but there was a risk that the needle had broken inside the surgical wound.30 min search for the 2 ends of the needle and control x-ray taken at the patient's site.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.It was reported that "no patient consequence, but there was a risk that the needle had broken inside the surgical wound.30 min search for the 2 ends of the needle and control x-ray taken at the patient's site." * please confirm if needle fell inside the patient.Was it retrieved during the same procedure? * what was done to retrieve the broken piece? for example, switched to and open procedure, second surgery? a manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.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, 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.
Event or Problem Description
It was reported that a patient underwent a laparotomy (left nephrectomy) procedure on (b)(6) 2024 and a suture device was used.The device had broken during closure of the aponeurosis in a patient operated on by laparotomy (left nephrectomy) no adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional information was requested, and the following was obtained: please confirm if needle fell inside the patient.Was it retrieved during the same procedure? the 2 fragments of needle were found (so not remained in the patient).What was done to retrieve the broken piece? for example, switched to and open procedure, second surgery? a control x-ray was performed in the patient.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, 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 CT BRD VIO 27IN 0 S/A MH
• 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: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 20645677
• Report Number: 2210968-2024-11745
• Device Sequence Number: 15311421
• Product Code: GAM
• UDI-Device Identifier: 17891338030407
• UDI-Public: (01)17891338030407(17)280430(10)SMBBGJT0
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 11/12/2024

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: J324H
• Device Lot Number: SMBBGJT0
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2024
• Supplement Date Received by Manufacturer: 11/08/2024
• Initial Report FDA Received Date: 11/08/2024
• Supplement Report FDA Received Date: 11/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/02/2022
• 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