MAUDE Adverse Event Report: ETHICON INC. MCRYL VIO 27IN 3-0 S/A CT-1; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	Y338H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Attempts have been made to retrieve the device.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.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Lot number for y338h?.
Event or Problem Description
It was reported that a patient underwent a unknown ob-gyn procedure on an unknown date and suture was used.The suture broke during use.There were no adverse patient consequences reported.
Additional Manufacturer Narrative
(b)(4).Additional information was requested and the following was obtained: lot number for y338h? no further information is available.No further information will be provided.

• Brand Name: MCRYL VIO 27IN 3-0 S/A CT-1
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8245945
• Report Number: 2210968-2019-78394
• Device Sequence Number: 11313343
• Product Code: GAN
• UDI-Device Identifier: 10705031058842
• UDI-Public: 10705031058842
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K960653
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2018

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 Catalogue Number: Y338H
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/18/2018
• Supplement Date Received by Manufacturer: 01/16/2019
• Initial Report FDA Received Date: 01/14/2019
• Supplement Report FDA Received Date: 02/06/2019
• Patient Sequence Number: 1