MAUDE Adverse Event Report: ETHICON INC. MCRYL VIO 27IN 2-0 S/A UR-6; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	Y605H
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.A manufacturing record evaluation was performed for the finished device batch, and no non-conformance's were identified.] investigation summary: investigation summary: visual analysis of the returned sample revealed that one sample, of product code y605, 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.According to the process specification, this is a class 1 defect.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.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 a patient underwent a myomectomy procedure on 06/07/2021 and suture was used.Before use on the patient, it was reported that the problem of pulling off suture needle had happened in the newly dispensed suture when it was opened to prepare for inferior myomectomy surgery.Upon evaluation of the device, 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.There were no patient consequences reported.No additional information was provided.

• Brand Name: MCRYL VIO 27IN 2-0 S/A UR-6
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12342626
• Report Number: 2210968-2021-07509
• Device Sequence Number: 14347242
• Product Code: GAN
• UDI-Device Identifier: 10705031059481
• UDI-Public: 10705031059481
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 07/26/2021

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: 09/30/2025
• Device Model Number: Y605H
• Device Catalogue Number: Y605H
• Device Lot Number: QLMDES
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2021
• Initial Date Received by Manufacturer: 07/26/2021
• Initial Report FDA Received Date: 08/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1