MAUDE Adverse Event Report: ETHICON INC. MCRYL VIO 27IN 0 S/A CT-1; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	Y340H
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint number: (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: what was the name of the procedure? no further information is available.What was the procedure date? no further information is available.No further information will be provided.A manufacturing record evaluation was performed for the finished device lot, and no non-conformance's were identified.Investigation summary: visual analysis of the returned sample revealed that one sample, of product code y340, 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.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 a quality system.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post-market surveillance.".
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and suture was used.It was found that the suture had been detached from the needle before use.It was not a control release needle.There were no adverse consequences to the patient.Additional information has been requested.

• Brand Name: MCRYL VIO 27IN 0 S/A CT-1
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12698454
• Report Number: 2210968-2021-10319
• Device Sequence Number: 11873815
• Product Code: GAN
• UDI-Device Identifier: 10705031058866
• UDI-Public: 10705031058866
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/26/2021

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: 10/31/2025
• Device Model Number: Y340H
• Device Catalogue Number: Y340H
• Device Lot Number: QMMHBS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2021
• Initial Report FDA Received Date: 10/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1