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

Model Number	J341H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a total open hysterectomy on (b)(6) 2021 and suture was used.During the procedure, the suture broke.Two units would be used, but when these broke another two were used, and the same thing happened.Another like device was used to complete the procedure.There were no patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint number: (b)(4).Component code: (b)(4) device not returned.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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: what was the initial procedure? total open hysterectomy.Could you confirm if the patient suffers any consequence due to the problem (suture break)? if yes, please explain.There is no report from the doctor about any consequences.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: 2210968-2021-12989, 2210968-2021-12990, 2210968-2021-12991.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 3/22/2022.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.H3 investigational narrative: visual analysis of the returned product revealed that an empty labeled winding formers and some suture pieces product code j341h were received to ethicon inc for evaluation.The strand was broken at several pieces during the inspection due to the degradation process caused by exposure to the environment.The foil was not received for evaluation.The product code j341h contains an absorbable suture.As the package was received open, the time of exposed to the environment could not be determined and functional test cannot be performed.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 ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.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 27IN 1 S/A CT-1
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-BRAZIL; rodovia presidente dutra; km 154; sao paolo ; BR
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 13090681
• Report Number: 2210968-2021-12988
• Device Sequence Number: 14880745
• Product Code: GAM
• UDI-Device Identifier: 10705031039056
• UDI-Public: 10705031039056
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2022

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: 03/31/2026
• Device Model Number: J341H
• Device Catalogue Number: J341H
• Device Lot Number: AP5228
• 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: 12/03/2021
• Supplement Date Received by Manufacturer: 03/07/2022
• Initial Report FDA Received Date: 12/27/2021
• Supplement Report FDA Received Date: 03/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/05/2021
• 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