MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD VIO 8X18IN 3-0 S/A SH CR; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	J774D
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint number: (b)(4).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, and the following was obtained: qty of product involved: 1 => 5 qty to be returned: 1 => 5 are there photos available for visual analysis? =>no photos are available.Procedure name? no further information is available.Please provide the status of the device(s) as it has not been received for analysis.If the device has been shipped, please provide the shipment tracking details.We regularly contact with sales rep about the device returning.No further information will be provided.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.Related to: 2210968-2022-00153, 2210968-2022-00154, 2210968-2022-00155, 2210968-2022-00156.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2021 and suture was used.Prior to use on the patient, when checking the sutures after the package was opened, a monofilament appeared to be mixed in the product.There were no patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint number: (b)(4).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, and the following was obtained: qty of product involved: 1 => 5 qty to be returned: 1 => 5 are there photos available for visual analysis? =>no photos are available.Procedure name? no further information is available.Please provide the status of the device(s) as it has not been received for analysis.If the device has been shipped, please provide the shipment tracking details.We regularly contact with sales rep about the device returning.No further information will be provided.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.Related to: 2210968-2022-00153, 2210968-2022-00154, 2210968-2022-00155, 2210968-2022-00156.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2021 and suture was used.Prior to use on the patient, when checking the sutures after the package was opened, a monofilament appeared to be mixed in the product.There were no patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 02/23/2022.H6 component code: g07002 - no device problem found.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.H3 investigation summary: an empty foil packet, one winding former with six used needles, two needle/sutures piece and 14 used sutures pieces of product code j774 were returned for analysis.The product code is multistrand and each packet contains eight strands.In order to evaluate the conditions of the returned sample, the swage and attachment area were noted to be as expected.The sutures were examined along of the strand to detect any issue related to incorrect component or monofilament suture and the sutures belong to vicryl suture, braided, violet color, length 18", diameter 3-0 with a needle sh, taper point, wire size 24 mil, correct for the product code j774, however a suture was observed wavy since he strand exhibits a zig-zag, this condition could be observed with an difference appearance.As part of quality process, all devices are manufactured, inspected, and released to approved specifications.

• Brand Name: VCL CT BRD VIO 8X18IN 3-0 S/A SH CR
• 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: 13185792
• Report Number: 2210968-2022-00152
• Device Sequence Number: 19900494
• Product Code: GAM
• UDI-Device Identifier: 10705031042919
• UDI-Public: 10705031042919
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2022

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: 08/31/2026
• Device Model Number: J774D
• Device Catalogue Number: J774D
• Device Lot Number: RKMESE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/14/2021
• Supplement Date Received by Manufacturer: 01/28/2022
• Initial Report FDA Received Date: 01/06/2022
• Supplement Report FDA Received Date: 02/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/11/2021
• 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