MAUDE Adverse Event Report: ETHICON INC. MCRYL VIO 36IN 1 S/A CTX; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	Y399H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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.The following information was requested, but unavailable: what is the lot number? no further information is available.
Event or Problem Description
It was reported that a patient underwent a cesarean section surgery on (b)(6) 2021 and suture was used.During the procedure, the needle detached from the suture while suturing the myometrium.No adverse patient consequences were 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 analysis: visual analysis of the returned sample revealed that one opened sample, of product code y399h, was received for evaluation.After investigation of the sample, short insertion was observed in the strand.The visual inspection concluded that the combination of the needle/suture was found detached since the insertion end of the suture did not meet the requirement.The defect is caused because the suture was not properly inserted inside of the needle barrel hole resulting in a pull-out defect.Based on the information currently available, the pull-out was identified during the investigation of the sample received.This product issue will be addressed through ethicon inc¿s quality system.

• Brand Name: MCRYL VIO 36IN 1 S/A CTX
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 13257538
• Report Number: 2210968-2022-00402
• Device Sequence Number: 11927960
• Product Code: GAN
• UDI-Device Identifier: 10705031059108
• UDI-Public: 10705031059108
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K960653
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2022

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 Model Number: Y399H
• Device Catalogue Number: Y399H
• 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: 12/20/2021
• Supplement Date Received by Manufacturer: 01/28/2022
• Initial Report FDA Received Date: 01/14/2022
• Supplement Report FDA Received Date: 02/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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