MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD VIO 27IN 1 S/A CT; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	J353H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Attempts have been made to retrieve the device.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: is the device available to be returned for evaluation? yes.No further information will be provided.Additional information was requested, and the following was unavailable: did the surgery was completed successfully? if yes, what was used to complete the procedure? a manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.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 an unknown ob-gyn surgery on (b)(6) 2021 and suture was used.The suture was detached from the needle during continuous suturing.It was not a control release needle.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 10/26/2021/ 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.H6 component code: g07002 unable to investigate further.Additional h3 investigation summary: visual analysis of the returned sample determined that an empty labeled winding former and a detached needle product code j353h were received to ethicon inc for evaluation.The product code is single-armed and on the needle, the swage and attachment area were noted to be as expected, body fluids and 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.

• Brand Name: VCL CT BRD VIO 27IN 1 S/A CT
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12538293
• Report Number: 2210968-2021-08893
• Device Sequence Number: 1240617
• Product Code: GAM
• UDI-Device Identifier: 10705031039209
• UDI-Public: 10705031039209
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,u
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2021

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: No Information
• Device Expiration Date: 02/28/2026
• Device Model Number: J353H
• Device Catalogue Number: J353H
• Device Lot Number: RCMJJP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2021
• Initial Date Received by Manufacturer: 09/02/2021
• Supplement Date Received by Manufacturer: 09/28/2021
• Initial Report FDA Received Date: 09/27/2021
• Supplement Report FDA Received Date: 10/26/2021
• Patient Sequence Number: 1