MAUDE Adverse Event Report: ETHICON INC. MCRYL VIO 36IN 2-0 S/A CT-2; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	Y762H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device lot number qlmlpb / y762h05, and no non-conformances related to the reported complaint condition were identified.Summary: visual analysis of the returned sample revealed that one sample, of product code y762, 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 pull-out has been correlated to the manufacturing process due to this 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 quality system.
Event or Problem Description
It was reported that an animal underwent an animal surgery on (b)(6) 2021 and the suture was used.Upon evaluation, short insertion was observed in the strand.

• Brand Name: MCRYL VIO 36IN 2-0 S/A CT-2
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12310009
• Report Number: 2210968-2021-07247
• Device Sequence Number: 3962781
• Product Code: GAN
• UDI-Device Identifier: 10705031059573
• UDI-Public: 10705031059573
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: distributor,health profession
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/27/2021

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: 09/30/2025
• Device Model Number: Y762H
• Device Catalogue Number: Y762H
• Device Lot Number: QLMLPB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2021
• Initial Report FDA Received Date: 08/11/2021
• Patient Sequence Number: 1