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

Catalog Number	Y605H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The following additional information was requested however not received to date: did the needle pull off issue before use on patient or during suturing? the manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Attempts to retrieve the device were made.To date no sample has been returned.If product is returned or further details are received at a later date a supplemental medwatch will be sent.
Event or Problem Description
It was reported a patient underwent an unknown surgery on (b)(6) 2019 and suture was used.The suture pulled off the needle while in the needle holder device clamped to draw the suture.Changed another one to complete the surgery.There is no reported patient consequence.No additional information could be provided.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Additional information was requested and the following was obtained: did the needle pull off issue before use on patient or during suturing? unknown.

• Brand Name: MCRYL VIO 27IN 2-0 S/A UR-6
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9168062
• Report Number: 2210968-2019-88471
• Device Sequence Number: 2830325
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2019

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: 01/31/2023
• Device Catalogue Number: Y605H
• Device Lot Number: MBK603
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/11/2019
• Supplement Date Received by Manufacturer: 10/09/2019
• Initial Report FDA Received Date: 10/08/2019
• Supplement Report FDA Received Date: 11/04/2019
• Patient Sequence Number: 1