MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD VIO 8X18IN 1 S/A CTX CR; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	J765D
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Additional information was requested, and the following was obtained: we got this info from the actual product on 18_january_2022 lot number: unknown rembtp.What was used to complete the procedure? =>no further information is available.What tissue was being approximated or sutured when it broke? no further information is available.Procedure name and date? no further information is available.Event date? no further information is available.Lot number? no further information is available.Device return status/follow up? we regularly contact with sales rep about the device returning.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.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and suture was used.During the procedure, the suture broke during suturing.There were no patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 02/24/2022.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: visual analysis of the returned product revealed that one empty foil packet, a used needle/suture piece and a winding former with two re-parked used needles and three undispensed strands of product code j765 were received for evaluation.The product code is single armed and each tray contains eight strands.Upon visual inspection of the returned sample, the needle/suture piece of the 12.75" was observed with body fluids, damaged at the surface and the end of the suture cutted and frizzy.After further evaluation crimping marks were observed on the surface suture possibly from a surgical instrument.Functional test could not be performed to this strand, due to condition observed.As with any device, care should be taken to avoid damage to the strand when handling.Avoid the crushing or crimping action of the surgical instruments, such as needle holders and forceps.The winding former contains three strands intact, the sutures were dispensed without problems and examined along to detect any issue related to reported complaint and no defect, damaged could be observed, the product code j765 contains an absorbable suture and due to the sample was received opened, the time of exposure could not be determined.Functional test was performed, to three strands and the tensile strength results were above the minimum requirements.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.As part of quality process, all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device, and no non-conformances were identified.

• Brand Name: VCL CT BRD VIO 8X18IN 1 S/A CTX 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: 13286158
• Report Number: 2210968-2022-00496
• Device Sequence Number: 17279913
• Product Code: GAM
• UDI-Device Identifier: 10705031042834
• UDI-Public: 10705031042834
• 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): 01/18/2022

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: 04/30/2026
• Device Model Number: J765D
• Device Catalogue Number: J765D
• Device Lot Number: REMBTP
• 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: 12/27/2021
• Supplement Date Received by Manufacturer: 01/28/2022
• Initial Report FDA Received Date: 01/18/2022
• Supplement Report FDA Received Date: 02/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/06/2021
• 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