MAUDE Adverse Event Report: ETHICON INC. MCRYL VIO 18IN 4-0 S/A P-3 PRM MP; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	Y464G
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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: confirm the total qty involved with reported issue during this procedure? 3 devices are reported.Confirm the lot # for all the devices involved with reported issue during this procedure? reported lot# is pgm779 only.Were the remaining 3 noticed with reported issue before use on patient while dispensing/handling ? or during use on patient while suturing ? no further information is available.No further information will be provided.Note: events reported in 2210968-2019-90543, 2210968-2019-90544, and 2210968-2019-90545.
Event or Problem Description
It was reported that a patient underwent an unknown surgery on an unknown date and suture was used.During the procedure, when trying to use the needle-suture, the suture was detached from the needle.There were no adverse consequences to the patient.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device lot pgm779, and no non-conformances were identified.

• Brand Name: MCRYL VIO 18IN 4-0 S/A P-3 PRM MP
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9412167
• Report Number: 2210968-2019-90544
• Device Sequence Number: 17176220
• Product Code: GAN
• UDI-Device Identifier: 10705031059269
• UDI-Public: 10705031059269
• 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): 11/15/2019

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: 05/31/2024
• Device Catalogue Number: Y464G
• Device Lot Number: PGM779
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/15/2019
• Supplement Date Received by Manufacturer: 12/16/2019
• Initial Report FDA Received Date: 12/04/2019
• Supplement Report FDA Received Date: 12/16/2019
• Patient Sequence Number: 1