MAUDE Adverse Event Report: ETHICON INC. MCRYL VIO 27IN 2-0 S/A CT-1; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	Y339H
Medical Device Problem Codes	Tear, Rip or Hole in Device Packaging (2385); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.The following information was requested, but unavailable: how was the procedure completed? lot number? investigation summary: the product was returned for evaluation.Visual inspection evaluation was conducted on the returned device.Visual analysis of the returned sample determined that one opened sample of product code y339h was received for evaluation, the swage and attachment area of the needle was noted to be as expected.The strands were broken in multiples pieces due to the suture has begun with the process of degradation.The foil was inspected and multiples holes in the cavity and excessive wrinkles were noted.This condition contributed to the degradation of the suture.The manufacturing records could not be reviewed as the batch number is unknown.It should be noted that as part of our quality process, the device is visually inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.
Event or Problem Description
It was reported that a patient underwent an unknown obgyn surgery on (b)(6) 2021 and suture was used.During the procedure, when a nurse was opening the package, it was found that the suture had been broken.There were no adverse consequences to the patient.Upon evaluation of the returned device, the foil was inspected and multiples holes in the cavity and excessive wrinkles were noted.No additional information was provided.

• Brand Name: MCRYL VIO 27IN 2-0 S/A CT-1
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 11665544
• Report Number: 2210968-2021-03338
• Device Sequence Number: 3015072
• Product Code: GAN
• UDI-Device Identifier: 10705031058859
• UDI-Public: 10705031058859
• 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): 03/19/2021

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 Model Number: Y339H
• Device Catalogue Number: Y339H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2021
• Initial Report FDA Received Date: 04/14/2021
• Patient Sequence Number: 1