MAUDE Adverse Event Report: ETHICON INC. MCRYL VIO 36IN 0 S/A CTX; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	Y398H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint number: (b)(4).Investigation summary: visual analysis of the returned sample revealed that one sample, of product code y398, was received to 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.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post-market surveillance.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.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 a c-section on (b)(6) 2022 and suture was used.During the procedure, the needle popped off the suture before it could even be used.Pop off occurred at the sewage.Another like device was used to complete the procedure.There were no patient consequences reported.

• Brand Name: MCRYL VIO 36IN 0 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.-JUAREZ; avenida de las torres 7125; col salvacar; cuidad juarez ; MX
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 13865800
• Report Number: 2210968-2022-02058
• Device Sequence Number: 5264329
• Product Code: GAN
• UDI-Device Identifier: 10705031059092
• UDI-Public: 10705031059092
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• 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: 08/31/2026
• Device Model Number: Y398H
• Device Catalogue Number: Y398H
• Device Lot Number: RKMJBB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2022
• Initial Report FDA Received Date: 03/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/16/2021
• 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