MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD VIO 18IN 4-0 S/A P-3 PRM MP; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	J464G
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an basal cell carcinoma removal on (b)(6) 2022 date and suture was used.During use on the patient the sutures have broken-the needle came off.Two sutures were broken.There were no patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint number: (b)(4).Additional information was requested, and the following was obtained: was there any adverse consequence associated with the patient? no.When was the suture broke-the needle came off (in the package, during removal from package, during handling or during use on the patient)? please specify.During use n the patient.Could you please clarify how many sutures are broken? 3.Could you please clarify how many needles came off? 3.Did the event occur during one or multiple patient procedures? multiple- 2 different patients.What is the total number of procedures? 2.Have any of these events been previously reported to ethicon? if so, provide the respective reference number(s).No.Please provide the lot number: rcmamu.Device return status: i do not have the broken sutures to return as they are in my sharps bin.I can however send the remaining box of sutures.How would you like me to proceed? please provide the date, and procedure name of the additional event.Please indicate how many needles broke during each procedure.On (b)(6) 2022 and excision of basal cell carcinoma and 2 sutures were broken.On (b)(6) 2022: cyst excision and 1 suture was broken.Additional information was requested: did the suture break or did the needle pull off the suture? 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.Related to: 2210968-2022-03441.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 5/24/2022.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: did the suture break or did the needle pull off the suture? the needle pulled off the suture all 3 times.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 Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 6/7/2022.H6 component code: g07002 no device problem found.H3 investigational summary: one empty opened box and five packets of product code j464g were returned to ethicon for analysis with the packaging closed.Upon initial inspection, of the samples, no external damages were observed on the packet.In order to evaluate the conditions of the returned samples, the five packets were opened, and no defects were detected.The swage and attachment area were noted to be as expected.The sutures were dispensed without problems and examined along the strand to detect any issue related no defects were observed during evaluation.Functional test was performed, and the pull force result were below the minimum requirements.The event described could not be confirmed as the device performed without any defect noted.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.It should be noted that as part of our quality process, each batch is randomly inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.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.

• Brand Name: VCL CT BRD VIO 18IN 4-0 S/A P-3 PRM MP
• 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
• MDR Report Key: 14345892
• Report Number: 2210968-2022-03442
• Device Sequence Number: 5198558
• Product Code: GAM
• UDI-Device Identifier: 10705031040151
• UDI-Public: 10705031040151
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: Health Professional,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/07/2022

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 Expiration Date: 02/28/2026
• Device Model Number: J464G
• Device Catalogue Number: J464G
• Device Lot Number: RCMAMU
• 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: 04/11/2022
• Supplement Date Received by Manufacturer: 05/10/2022; 05/23/2022
• Initial Report FDA Received Date: 05/10/2022
• Supplement Report FDA Received Date: 05/24/2022; 06/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/02/2021
• 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