MAUDE Adverse Event Report: ETHICON INC. MCRYL VIO 36IN 2-0 S/A SH; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	Y732H
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/29/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.The product upon which this medwatch is based has been received, however, the product evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.
Event or Problem Description
It was reported that an animal underwent an unknown procedure on (b)(6) 2018 and suture was used.During the procedure, the suture detached from the needle.Another like device was used to complete the procedure.There were no adverse consequences for the animal.No additional information was provided.
Additional Manufacturer Narrative
Pc-(b)(4).Date sent to the fda: (b)(4) 2018.Two empty labeled winding formers of product code (b)(4) were returned for analysis.No suture or needle were returned for evaluation to determine the assignable cause therefore, the reported failure could not be evaluated.The manufacturing records were reviewed and the manufacturing/ packaging criteria were met prior to the release of this batch.It could not be determined what may have caused the reported incident.

• Brand Name: MCRYL VIO 36IN 2-0 S/A SH
• 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: 7634134
• Report Number: 2210968-2018-73729
• Device Sequence Number: 2412330
• Product Code: GAN
• UDI-Device Identifier: 10705031059528
• UDI-Public: 10705031059528
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K960653
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2018

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 Expiration Date: 03/31/2022
• Device Catalogue Number: Y732H
• Device Lot Number: LDK040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2018
• Initial Date Received by Manufacturer: 05/30/2018
• Supplement Date Received by Manufacturer: 06/15/2018
• Initial Report FDA Received Date: 06/25/2018
• Supplement Report FDA Received Date: 07/11/2018
• Patient Sequence Number: 1