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

Model Number	Y341H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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.Additional information was requested, and the following was obtained: could you please confirm the procedure/ event date? alert date appears to be (b)(6) however procedure/ event date was entered as (b)(6).Both the alert date and procedure/ event date are (b)(6) 2021.A manufacturing record evaluation was performed for the finished device lot, and no non-conformance were identified.Event related to mw # 2210968-2021-07425.
Event or Problem Description
It was reported that a patient underwent an ob-gyn procedure on (b)(6) 2021 and suture was used.The suture broke during continuous suturing.No adverse patient consequences were reported.Additional information was requested.

• Brand Name: MCRYL VIO 27IN 1 S/A CT-1
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12333920
• Report Number: 2210968-2021-07423
• Device Sequence Number: 4713199
• Product Code: GAN
• UDI-Device Identifier: 10705031058873
• UDI-Public: 10705031058873
• 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): 07/28/2021

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: 01/31/2026
• Device Model Number: Y341H
• Device Catalogue Number: Y341H
• Device Lot Number: RBMCPT
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2021
• Initial Report FDA Received Date: 08/17/2021
• Patient Sequence Number: 1